3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS. SOLVENTUM IS UNABLE TO VERIFY THE LEAK, IDENTIFY EXACT LOCATION AND ROOT CAUSE WITHOUT THE SAMPLE. BASED ON THE PROBLEM DESCRIPTION THE REPORTED ISSUE IS A Y CONNECTOR LEAK. EXCESSIVE HANDLING OR STRESS PUT ON THE Y CONNECTOR TUBING CONNECTIONS, OR OVER PRESSURIZATION OF THE SET ABOVE 300 MMHG CAN RESULT IN A LEAK. A REVIEW OF THE BATCH RECORD SHOWED THIS LOT MET ALL SPECIFICATION FOR PRODUCT RELEASE AND NO DEVIATIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED MALFUNCTION. SOLVENTUM WILL CONTINUE TO MONITOR.

Description of Event or Problem

IT WAS REPORTED THAT THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE Y-CONNECTOR NEAR THE PRESSURIZED BLOOD BAG DURING A MASSIVE BLOOD TRANSFUSION. THERE WERE NO REPORTED INJURIES OR MEDICAL INTERVENTIONS ALLEGED AS A RESULT OF THE REPORTED MALFUNCTION.