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

Description of Event or Problem

IT WAS REPORTED DURING TRANSPORT, THE SPIKE ON THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SEPARATED FROM THE TUBING, RESULTING IN PACKED RED BLOOD CELLS SPILLING ON THE FLOOR. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.

Additional Manufacturer Narrative

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