FDA Adverse Event Death Summary report: N

CRESCENT RA DUAL LUMEN

MDR report key: 15893965 · Received December 1, 2022

Report

Report Number
MW5113556
Event Type
Death
Date Received
December 1, 2022
Date of Event
September 29, 2022
Report Date
November 30, 2022
Manufacturer
MEDTRONIC/MC3 INC.
Product Code
PZS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

PT EXPERIENCED AN ACUTE DETERIORATION BEGINNING 11:38-11:40AM ON (B)(6) 2022 RESULTING IN A CARDIAC ARREST AND, ULTIMATELY, CARDIAC DEATH. ON TELE FROM 11:37-11:40, PROFOUND HYPOTENSIVE SEEN INITIALLY, THEN HYPOXEMIA AND BRADYCARDIA LEADING INTO A CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY. PEDS SURG WAS CALLED QUICKLY TO DISCUSS CONVERSION TO VA ECMO. PEDS SURG ARRIVED TO BEDSIDE, CONCERN FOR POSS TENSION PNEUMO DISCUSSED. NEEDLE DECOMPRESSION, WITH NO RETURN OF AIR--RATHER, SEROSANGUINOUS OUTPUT. PLACED L&R CHEST TUBES AS THE ECMO AND OPERATING ROOM TEAMS MOBILIZED TO PREPARE CONVERSION TO VA ECMO. UPON PLACEMENT OF BILATERAL CHEST TUBES, ONLY SEROSANGUINEOUS OUTPUT WAS OBSERVED--NO AIR. NEXT, UNDER US GUIDANCE, PHYSICIAN PLACED A NEEDLE TO DECOMPRESS THE PERICARDIAL SPACE--APPROX 20-30CC OF FRANK RED BLOOD WERE DRAINED, THOUGH STILL WITH NO SUBSEQUENT RETURN OF CARDIAC ACTIVITY. AT THIS POINT, THE PEDIATRIC SURGERY TEAM, ECMO, AND OPERATING ROOM TEAMS WERE PREPARED FOR CONVERSION TO VA ECMO(VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION). APPROX 30 MINUTES HAD PASSED PERFORMING CHEST COMPRESSIONS AND GIVING RESUSCITATION DRUGS TO THIS POINT. GIVEN CONCERN FOR FUTILITY OF CONVERTING ECMO MODES GIVEN THE LENGTH OF CPR, A BLOOD GAS WAS OBTAINED AND SHOWED: 7.41/35/80/22/-2.1/14.2 IT WAS AGREED UPON THAT CONVERSION TO VA ECMO WAS STILL A REASONABLE AND NON-FUTILE LIFESAVING INTERVENTION WORTH PURSUING. PT PREPPED AND BEGAN THE PROCESS OF ARTERIAL CANNULATION. PEDS CT SURGERY ALSO ARRIVED TO BEDSIDE TO DISCUSS OPEN CHEST AND ASSIST. DECISION MADE TO PROCEED WITH FASTEST CONVERSION METHOD, PERIPHERAL VA. DURING THE PROCESS OF PERIPHERAL ARTERIAL CANNULATION, RESUSCITATION CONTINUED WITH NO RETURN OF SPONTANEOUS CIRCULATION BY THE 60 MINUTE MARK OF CPR, FLOWS THROUGH THE ARTERIAL LIMB WERE NOT ESTABLISHED AND PROCEEDING WITH FURTHER RESUSCITATION OR LIFESAVING INTERVENTIONS WAS DEEMED FUTILE. THE CODE EVENT WAS STOPPED AT 12:40PM. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1788264 CRESCENT RA DUAL LUMEN DUAL LUMEN ECMO CANNULA PZS MEDTRONIC/MC3 INC.

Patients

Seq Age Sex Outcome Treatment
1 3 YR Female Death