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

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS AND NO LOT NUMBER WAS PROVIDED; THEREFORE, SOLVENTUM IS UNABLE TO VERIFY THE LEAK OR IDENTIFY EXACT LOCATION WITHOUT A SAMPLE. THE HOSPITAL MANAGER REPORTED AN INTERNAL INVESTIGATION DETERMINED THAT USE ERROR OCCURRED RELATED TO THE TUBING NOT BEING FULLY TIGHTENED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: WARNING: TO REDUCE THE RISKS OF BIOHAZARD EXPOSURE, CROSS-CONTAMINATION OR INFECTION: ENSURE THAT ALL LUER CONNECTIONS ARE SECURELY TIGHTENED PRIOR TO PRIMING SET.

Description of Event or Problem

A USER FACILITY REPORTED AN INCIDENT THAT OCCURRED A FEW MONTHS AGO WHERE THE TUBING OF 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SPRAYED BLOOD DURING USE. THE FACILITY MANAGER REPORTED THAT AN INVESTIGATION WAS COMPLETED AND THE CONCLUSION WAS THAT USE ERROR OCCURRED RELATED TO THE TUBING NOT BEING FULLY TIGHTENED. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION. A SECOND SIMILAR EVENT OCCURRED AGAIN APPROXIMATELY 3-4 WEEKS AGO. THE MANAGER EXPRESSED CONCERN THAT THE PRODUCT DESIGN MAY BE CONTRIBUTING TO THE LEAK(S) AND THAT STAFF SHOULD NOT HAVE TO WORRY ABOUT WHETHER CONNECTIONS HAVE BEEN SUFFICIENTLY TIGHTENED.