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

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO SOLVENTUM FOR ANALYSIS, AND A HEAT EXCHANGER LEAK WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF HEAT EXCHANGER LEAKS INCLUDE OVER-PRESSURIZATION ABOVE 300MMHG, INSERTION OR REMOVAL OF PRESSURIZED HEAT EXCHANGER FROM HEATING UNIT, AND HEAT EXCHANGER NOT FULLY INSERTED INTO THE HEATING UNIT. 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 A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE CASSETTE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.