LEVEL 1 FLUID WARMER IV SET

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IN CARDIAC ARREST FROM A DISSECTION. THEY WERE ATTEMPTING TO GIVE MULTIPLE UNITS OF BLOOD THROUGH THE LEVEL 1 INFUSER, BUT THE TUBING KEPT KINKING AND THIS CAUSED DECREASED FLOW AND PROLONGED TIME TO GIVE BLOOD TO THE PATIENT. THEY HAD TO SUPPLEMENT THE LEVEL 1 INFUSER WITH GIVING BLOOD THROUGH A PRESSURE BAG UNTIL THEY COULD GET THE TUBING UNKINKED. THEY WERE UNABLE TO PUNCTURE BLOOD BAG WITH LEVEL 1 INFUSER TUBING IN A CRITICAL SITUATION WITH A PATIENT. IT TOOK SEVERAL TRIES BY MULTIPLE PEOPLE TO PUNCTURE THE BLOOD BAG WITH THE TUBING. THE PATIENT ULTIMATELY DID NOT SURVIVE. THERE WAS PATIENT INVOLVEMENT, AND PATIENT DEATH WAS REPORTED WHILE USING ICU PRODUCT. THE DEVICE AND PATIENT DEATH WERE NOT RELATED. MEDICAL EVALUATION: BASED ON THE AVAILABLE INFORMATION, THERE IS NO OBJECTIVE EVIDENCE CONFIRMING A DEVICE MALFUNCTION, AS NO DEVICE OR LOT WAS AVAILABLE FOR EVALUATION. ADDITIONALLY, ALTERNATIVE TRANSFUSION METHODS WERE SUCCESSFULLY EMPLOYED TO CONTINUE THERAPY. WHILE THE REPORTED DEVICE PERFORMANCE ISSUES MAY HAVE CONTRIBUTED TO PROCEDURAL DELAYS, THE PRIMARY CAUSE OF DEATH IS MOST CONSISTENT WITH THE UNDERLYING MEDICAL CONDITION. IN SUMMARY, THE RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT OUTCOME IS ASSESSED AS NOT ESTABLISHED, THOUGH A CONTRIBUTORY ROLE CANNOT BE EXCLUDED DUE TO THE REPORTED FLOW LIMITATION AND ACCESS DIFFICULTIES DURING A TIME-CRITICAL RESUSCITATION.