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

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO SOLVENTUM FOR ANALYSIS; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE PROBLEM DESCRIPTION, THE REPORTED ISSUE IS MOST LIKELY A HEAT EXCHANGER LEAK. 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

A USER FACILITY REPORTED THE CASSETTE ON THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET BURST WHILE IN USE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.