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

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO SOLVENTUM FOR ANALYSIS; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WAS LOCATED ON THE FDA MAUDE DATABASE, AND REPORTER INFORMATION WAS NOT DISCLOSED. 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

PER REVIEW OF REPORT MW5188615 ON THE MAUDE DATABASE: DURING INFUSION OF FRESH FROZEN PLASMA, THE SPIKE WAS PULLED OUT OF THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET. THERE WERE NO REPORTED INJURIES OR MEDICAL INTERVENTIONS ALLEGED AS A RESULT OF THE REPORTED MALFUNCTION.