Case report
Total spinal block after local anesthetic administration through the wrong access port of a spinal infusion pump
Bloqueo espinal total tras administración de anestésico local por el puerto de acceso equivocado de una bomba de infusión intratecal
Sensar
Sistema Español de Notificación en Seguridad en Anestesia y Reanimación (SENSAR), Spain
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We describe the incident, analyse its causes, and describe the measures taken to avoid similar incidents in the future and promote a hospital-wide safety culture.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The incident occurred in the post-anaesthesia care unit (PACU), where pain management techniques are usually performed, and involved a 63-year-old female patient with a programmable intrathecal infusion pump (Prometra II<span class="elsevierStyleSup">®</span> Pump, Flowonix Medical Inc, New Jersey, USA) implanted 1 year previously due to post-laminectomy syndrome refractory to conventional treatment. Other history of interest included: recent Ludwig's angina that had required emergent tracheotomy, epilepsy, hypertension and hard-to-control diabetes mellitus. The patient visited the hospital to refill the reservoir of the infusion pump for continuous infusion of morphine and bupivacaine, according to the line 3 approach recommended by the Polyanalgesic Consensus Conference of 2007. The following medication was prepared: 22<span class="elsevierStyleHsp" style=""></span>ml of 0.75% bupivacaine and 3<span class="elsevierStyleHsp" style=""></span>ml of 4% morphine hydrochloride. Following initial administration of 165<span class="elsevierStyleHsp" style=""></span>mg bupivacaine, the patient presented general weakness and respiratory distress followed by respiratory arrest. Suspecting direct intrathecal administration that could have caused total spinal block, emergent endotracheal intubation was performed following administration of 2<span class="elsevierStyleHsp" style=""></span>mg midazolam, 100<span class="elsevierStyleHsp" style=""></span>mg propofol and 75<span class="elsevierStyleHsp" style=""></span>mg succinylcholine. The GlideScope<span class="elsevierStyleSup">®</span> videolaryngoscope (Verathon Inc., Bothell, USA) was used, obtaining a Cormack-Lehane III laryngeal view. The patient was maintained haemodynamically stable under mechanical ventilation and transferred to the intensive care unit, where she was extubated without incident 2<span class="elsevierStyleHsp" style=""></span>hours after the event. She was admitted to hospital for 48<span class="elsevierStyleHsp" style=""></span>hours observation, and after 24<span class="elsevierStyleHsp" style=""></span>hours the reservoir of the pump was refilled without incident. This critical incident was considered a major morbidity due to the life-threatening respiratory arrest; however, the event was managed correctly and the patient made a full recovery.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Analysis of the incident and discussion</span><p id="par0015" class="elsevierStylePara elsevierViewall">This case involves a medication administration error. This type of error is preventable, and stems from an inappropriate and potentially harmful use of medication. It can be caused by factors associated with the medical professional, the patient, the prescription, patient-doctor or doctor-doctor communication, labelling, packaging, dispensing, distribution or administration of the drug.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a> Medication errors are common in incident reporting systems, and account for up to 8.9% of errors for every 100 drugs prescribed.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a> Due to their high human and economic cost, these events have received much attention in the literature in recent years, and are the subjects of several risk management programmes.</p><p id="par0020" class="elsevierStylePara elsevierViewall">In this case in particular, the physicians responsible for refilling the reservoir of the infusion pump had no training in the technique and were performing it for the first time. Fully implantable intrathecal infusion pumps are made up of 2 components: the programmable infusion pump, which is usually implanted in the subcutaneous tissue of the abdominal wall or the buttock region, and the intrathecal catheter, which is tunnelled subcutaneously from the pump to the site of spinal entry. The pump has a central port for percutaneous drug administration into a reservoir and a second, smaller, peripheral port with direct access to the intrathecal catheter, allowing the administration of boluses of medication and the injection of radiological contrast if myelography is needed to confirm correct placement of the pump (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">3</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">After the incident, it was found that reservoir had been refilled through the myelography port because a Medtronic<span class="elsevierStyleSup">®</span> refill kit (Medtronic Inc, Minneapolis, USA) was used in error, instead of the Prometra<span class="elsevierStyleSup">®</span> pump refill kit. The specialised staff of the Pain Unit did not perform a check-list prior to the procedure, and therefore did not notice that the wrong kit was being used. Furthermore, certain safety barriers were ignored: the staff attempted to refill a 20<span class="elsevierStyleHsp" style=""></span>ml reservoir with 25<span class="elsevierStyleHsp" style=""></span>ml of medication; they used the wrong template to identify the port; positive aspiration prior to refill was considered normal because some medication always remains, which is aspirated and discarded; and the medication was not injected slowly.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Intrathecal administration of opioids and/or local anaesthetics (fourth step in the WHO analgesic ladder) can significantly improve pain relief in patients with pain that is resistant to oral or intravenous medication, or that require extremely high doses that are associated with specific or systemic side effects. When intrathecal bupivacaine-morphine mixtures are used, bupivacaine-induced adverse effects (sensory or motor deficits, autonomic dysfunction, neurotoxicity) may occur with doses in excess of 30–60<span class="elsevierStyleHsp" style=""></span>mg/day. These effects generally, though not always, decrease with continuous infusion.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">4</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">In the case presented here, the medication administration error caused total spinal block, which is a serious, life-threatening accident if it is not diagnosed and treated immediately. Total spinal block occurs when a bolus dose of local anaesthetic is accidentally injected into the subarachnoid instead of the epidural space, or when an excessively high dose of local anaesthetic is injected into the intrathecal space (as in this case). The local anaesthetic spreads far enough cephalad in the spinal canal to completely block the spinal cord, and occasionally the brainstem. Onset of symptoms is rapid (usually less than 1<span class="elsevierStyleHsp" style=""></span>minute) serious and dramatic, and are the result of a complete sympathetic blockade with profound hypotension and bradycardia. Respiratory arrest may also occur as a result of paralysis of the respiratory musculature or dysfunction of the respiratory control centres in the brainstem. This may be accompanied by total paralysis of the limbs and thorax, and altered level of consciousness. Management strategies include administration of vasopressors, atropine and fluids to support the cardiovascular system, as well as oxygenation and controlled ventilation; cardiopulmonary resuscitation manoeuvres may also be required. If the cardiovascular and respiratory symptoms are treated correctly, the total spinal block is usually resolved without sequelae. Recovery time will depend on the type and dose of local anaesthetic administered in the subarachnoid space and the delay in starting treatment.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">5</span></a> The duration of action of bupivacaine is180-210<span class="elsevierStyleHsp" style=""></span>min, with a maximum dose of 200<span class="elsevierStyleHsp" style=""></span>mg.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The incident was reported to the Anestic platform (<a id="intr0010" class="elsevierStyleInterRef" href="http://www.anestic.sensar.org/">www.anestic.sensar.org</a>) and the local analysis group identified the active error and studied the latent systemic or organisational factors that could have contributed to the event. The incident was typified as a medication administration error. The active error was a mistake stemming from poor understanding of the intrathecal infusion system.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The analysis identified the following latent factors (according to Sensar's proprietory “PITELO” analysis methodology) as contributors to the incident<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">7</span></a>:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">–</span><p id="par0050" class="elsevierStylePara elsevierViewall">Patient-related factors: no patient-related factors were found. However, it should be noted that the patient presented complex previous pathology and difficult airway due Ludwig's angina.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">–</span><p id="par0055" class="elsevierStylePara elsevierViewall">Operator-related factors: lack of knowledge and inexperience, unequal training of the members of the Pain Unit.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">–</span><p id="par0060" class="elsevierStylePara elsevierViewall">Procedure-related factors: non-compliance with universal protocols for intrathecal pump filling, as well as the absence of protocols in the Unit itself.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">–</span><p id="par0065" class="elsevierStylePara elsevierViewall">Team-related factors: failure to communicate with other doctors (another doctor was familiar with these systems but was not asked for help).</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">–</span><p id="par0070" class="elsevierStylePara elsevierViewall">Workplace-related factors: lack of material resources, since the refill kit commercialised by the pump manufacturer was not available, only the myelography kit from another manufacturer.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">–</span><p id="par0075" class="elsevierStylePara elsevierViewall">Organisation-related factors: training policy, since the Pain Unit employs professionals with insufficient training in certain fields, and not all members receive the same training. Failures in the safety policy also contributed.</p></li></ul></p><p id="par0080" class="elsevierStylePara elsevierViewall">The measures taken by the local analysis team included: a meeting to communicate the incident, presentation of the case to the Pain Unit, publication of an alert in the local newsletter. Finally, the team recommended better training for Pain Unit staff.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Recommendations</span><p id="par0085" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">–</span><p id="par0090" class="elsevierStylePara elsevierViewall">Implementation of a check-list for these procedures.</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">–</span><p id="par0095" class="elsevierStylePara elsevierViewall">Refill intrathecal pump according to safety standards and under continuous monitoring.</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">–</span><p id="par0100" class="elsevierStylePara elsevierViewall">Always inject the local anaesthetic before the opioid, to minimise possible adverse effects.</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">–</span><p id="par0105" class="elsevierStylePara elsevierViewall">Equal training for the members of the Pain Unit.</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Ethical responsibilities</span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Protection of human and animals</span><p id="par0110" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this study.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Data confidentiality</span><p id="par0115" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols implemented in their place of work regarding the use of patient data in publications.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Right to privacy and informed consent</span><p id="par0120" class="elsevierStylePara elsevierViewall">Right to privacy and informed consent.</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Conflict of interests</span><p id="par0125" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:10 [ 0 => array:3 [ "identificador" => "xres1018467" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec976833" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1018466" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec976834" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Description of the incident" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Analysis of the incident and discussion" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Recommendations" ] 7 => array:3 [ "identificador" => "sec0020" "titulo" => "Ethical responsibilities" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0025" "titulo" => "Protection of human and animals" ] 1 => array:2 [ "identificador" => "sec0030" "titulo" => "Data confidentiality" ] 2 => array:2 [ "identificador" => "sec0035" "titulo" => "Right to privacy and informed consent" ] ] ] 8 => array:2 [ "identificador" => "sec0040" "titulo" => "Conflict of interests" ] 9 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2017-03-21" "fechaAceptado" => "2017-07-05" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec976833" "palabras" => array:2 [ 0 => "Total spinal block" 1 => "Spinal infusion pump" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec976834" "palabras" => array:2 [ 0 => "Bloqueo espinal total" 1 => "Bomba infusión intratecal" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">We present a case reported on the SENSAR database. A patient with a spinal infusion pump was admitted for reservoir refill. On administration of 22<span class="elsevierStyleHsp" style=""></span>ml of 0.75% bupivacaine the patient suffered a total spinal block with widespread loss strength and respiratory arrest. The patient required emergency orotracheal intubation, mechanical ventilation and admission to ICU, where extubation was achieved within two hours without incidences. At a later stage it was stated that the local anaesthetic had been administered via the access port for bolus or contrast administration instead of via the access to the reservoir.</p><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Analysis of the incident showed up latent factors related to absence lack of personnel training and internal protocols. The following measures were taken: pain unit meeting, alert sent to SENSAR bulletin and training request for members of the service.</p></span>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Presentamos un caso comunicado en la base de datos del Sistema Español de Notificación en Seguridad en Anestesia y Reanimación (SENSAR). Trata de una paciente portadora de bomba de infusión intratecal que acudió para recarga del reservorio. Al administrar 22<span class="elsevierStyleHsp" style=""></span>ml de bupivacaína al 0,75% la paciente presentó un bloqueo espinal total (pérdida de fuerza y parada respiratoria). Requirió intubación orotraqueal emergente, ventilación mecánica e ingreso en la UCI, donde se extubó sin incidencias tras 2 h. Posteriormente, se constató que se había administrado el anestésico local por el puerto de acceso para bolos o contraste radiológico y no por el de acceso al reservorio.</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">El análisis del incidente evidenció factores latentes relacionados con falta de formación del personal facultativo y carencia de protocolos internos. Se tomaron las siguientes medidas: reunión en la Unidad del Dolor, envío de alerta al boletín de SENSAR y solicitud de formación para los integrantes del servicio.</p></span>" ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: SENSAR. Bloqueo espinal total tras administración de anestésico local por el puerto de acceso equivocado de una bomba de infusión intratecal. Rev Esp Anestesiol Reanim. 2018;65:e5–e8.</p>" ] ] "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 626 "Ancho" => 1250 "Tamanyo" => 70209 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Implanted intrathecal pump.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Drug errors: consequences, mechanisms, and avoidance" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "R.J. 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