| Model Number PM040-A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cardiac Arrest (1762); Death (1802); Toxicity (2333); Reaction (2414); No Code Available (3191)
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| Event Date 12/28/2017 |
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Event Type
Death
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by (b)(6) health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to (b)(6) health.(b)(6) health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the (b)(6) health complaint database and identified as complaint (b)(4).
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Event Description
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(b)(6) received a single report that referenced once incident, which was associated with two separate units, involving a single patient.This is the first of two reports.Refer to 2026095-2018-00006 for the second catheter.Fill volume: n/a, flow rate: n/a, procedure: nuss procedure for pectus excavatum technique, cathplace: bilateral chest.It was reported that during an elective nuss procedure for pectus excavatum technique, two catheters were placed by two different doctors.Dr.(b)(6) placed the catheter with the guidance and help of dr.(b)(6) an incision was made laterally and a 11x12 tunneler was used to insert the catheter.The tunneler went in superficially.The tunneler was in position and the catheter was placed on the right side without any issues.Dr.(b)(6) was in the process of placing the catheter on the left side while dr.(b)(6) began to push through the bolus into the right sided catheter.The medication that was called out for the bolus was 8cc 0.5% plain marcaine.(b)(6) spoke up and informed dr.(b)(6) that typically with all the other cases, 5cc of marcaine was used a bolus.Dr.(b)(6) informed him it was okay to proceed because dr.(b)(6) (the anesthesiologist) did the calculations for the medication and it should be correct.Therefore, dr.(b)(6) began to bolus the catheter on the right side of the body.Within approximately one minute after the bolus was injected dr.(b)(6), the anesthesiologist knew something was wrong after looking at her monitor.She was alarmed and started to call out "lipids, pharmacy!" a code was called, and chest compressions were started.They were able to get a pulse on the patient but shortly after she coded again.The team worked to revive the patient.A central line was place, blood transfusions took place, and they had a helicopter on stand by to take the patient to a trauma center once she was stable enough.The patient was eventually placed on a gurney and on her way to the helicopter, however she coded again.The team eventually pronounced her death around 12pm.The cause of death has not been confirmed.There was speculation that it could have been a inner vasculature injection of the medication but they felt that it would be nearly impossible that a round blunt tip of the tunneler could enter a vessel.Per additional information received on (b)(6) 2018, at the time of the event, the second catheter had been placed, but no bolus started.Additional information has been requested, but not be provided at this time.
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Manufacturer Narrative
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Multiple attempts were made to the reporting facility via telephone calls and emails to try to get more information regarding the device product code and lot number, actual samples involved in the incident, as well as the autopsy results.After multiple attempts and conversations with the reporting facility and with the medical examiner/coroner¿s office, no additional device specific information was provided by the facility.No sample was returned for evaluation, and no product lot number was provided by the reporting facility.Therefore, no sample evaluation could be performed, and no device history record review could be performed.No root cause related to the halyard on-q catheters-soaker could be determined.A use review was performed by a halyard clinician on the marcaine reportedly used with the device during the procedure.Per the use review: the medication that was allegedly used in this case was marcaine (bupivicaine).Per the marcaine drug label, systemic absorption of local anesthetics may cause effects on the cardiovascular and central nervous systems (cns).At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal.However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities.In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure.Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine, which is a component of marcaine.Therefore, incremental dosing is necessary.A warning is provided by the marcaine (bupivicaine) drug label stating the following: ¿local anesthetics should only be employed by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies.(see also adverse reactions and precautions.) delay in proper management of dose-related toxicity, underventilation from any cause and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and, possibly, death.¿ therefore, use of marcaine may have contributed to the reported event that resulted in cardiac arrest and reported patient death.Based upon the limited information provided, however, halyard could not determine the true root cause of this incident and whether the halyard on-q catheters-soaker contributed to the event.All information reasonably known as of (b)(6) 2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
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Manufacturer Narrative
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Facility submitted user facility reports mw5074913 and (b)(4) to fda.All information reasonably known as of 02 mar 2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
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Event Description
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Per additional information received 06 feb 2018 via user facility report mw5074913, "intraoperative cardiopulmonary arrest and death during pectus excavatum surgery with use of the halyard on-q antimicrobial catheter" per additional information received 27 feb 2018 via user facility report (b)(4), "preoperative plan was to place an on-q pump for local anesthesia.The on-q representative was present in the operating room to assist with any questions.Per the physician documentation: a 2 mm incision was made, the on-q trocar was then advanced in the subcutaneous tissue above the fascia and followed laterally and posteriorly toward the scapula by direct palpitation for approximately 8 cm.After this was well positioned, the trocar was removed, leaving the sheath.There was no bleeding noted.The on-q pump tubing was then advanced through the sheath.The sheath was then withdrawn and the catheter tubing appeared to be in appropriate position and was palpated in the subcutaneous soft tissue.The catheter tubing was aspirated and there was no bleeding noted, and then 5 ml of 0.5% bupivacaine was injected into the on-q tubing with a 5 cc syringe.This appeared well tolerated.An additional 3 ml of 0.5 % bupivacaine was injected into the port tubing.The on-q trocar was then advanced subcutaneously on the left and demonstrated to be subcutaneous by palpation.At this point the trocar was removed leaving the sheath after being advanced toward the scapula for approximately 8 cm.The on-q tubing was the advanced into the sheath, and the sheath was then withdrawn leaving the on-q tubing in place.At this point, the anesthesiologist reported that the patient appeared to be in arrest.Chest compressions were initiated and after 4 hours of cpr, the patient was declared deceased.".
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Manufacturer Narrative
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No code available: intravascular toxicity.All information reasonably known as of 27-apr-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
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Event Description
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Additional information received 16-apr-2018, autopsy report.Findings: 1.Sudden cardiac arrest following bupivacaine administration through catheter routed into subcutaneous adipose tissue while under sedation prior to commencement of surgical correction of pectus excavatum.A.Refractory to extensive cardiopulmonary resuscitation which included administration of intralipid.B.Catheter removed by medical personnel after cardiac arrest.C.Bupivacaine in vials that administered drug was drawn from of expected concentration; specimens submitted directly to toxicology laboratory from (b)(6) medical center at (b)(6).2.Structurally normal heart examination that included conduction system study.Conclusion: i am of the opinion that (b)(6), a (b)(6) female, died as a result of bupivacaine cardiac toxicity.Reasons for this sudden cardiac arrest include intravascular placement of the catheter or an adverse/idiosyncratic drug reaction.Manner of death: accident.
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Search Alerts/Recalls
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