BUDDY¿ DISPOSABLE SET (1 PIECE)

Additional Manufacturer Narrative

THE INTERNAL COMPLAINT FILE # (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO BELMONT FOR INVESTIGATION. PER MEDWATCH REPORT # MW5162494, THE DATE OF EVENT IS NOV 05, 2024, BUT THE USER FACILITY DID NOT INFORM BELMONT ABOUT THIS INCIDENT WHEN IT ACTUALLY OCCURRED. WE BECAME AWARE OF THIS INCIDENT ON DECEMBER 5TH, AFTER RECEIVING THE MEDWATCH REPORT THEREFORE, REPORTING THIS NOW. THE USER WILL LOSE THE ABILITY TO INFUSE THE PATIENT WITH BUDDY LITE DURING THE LEAK. ANOTHER DISPOSABLE SET OR ALTERNATIVE METHODS CAN BE USED TO INFUSE THE PATIENT. THE OPERATOR'S MANUAL PROVIDES INSTRUCTIONS ON INSTALLING THE DISPOSABLE SET AND RECOMMENDED OPERATOR ACTIONS.THE STEP-BY-STEP PROCEDURES IN MANUAL HAS WARNING ON INSTALLING THE DISPOSABLE, " CAREFULLY REMOVE THE DISPOSABLE FROM ITS POUCH. INSTALL IT INTO THE HEATER UNIT, BEING CAREFUL TO LINE UP THE RED ORIENTATION HUB ON THE DISPOSABLE WITH THE NOTCH MARKED WITH A RED ARROW ON THE HEATER UNIT. TAKE CARE NOT TO DAMAGE THE DISPOSABLE". ALL 3 DISPOSABLE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING AND RELEASE FOR SHIPMENT FROM BELMONT MEDICAL TECHNOLOGIES. NEITHER BUDDY LITE NOR BUDDY DISPOSABLE SET WERE PROVIDED TO BELMONT FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION OF THE DISPOSABLE COULD NOT BE CARRIED OUT. THE SERIAL NUMBER AND LOT NUMBER OF THE DEVICE AND DISPOSABLE SET WERE UNKNOWN. NO INVESTIGATION COULD BE CARRIED OUT INTO THE DEVICE AND LOT HISTORY. NO OTHER ADDITIONAL INFORMATION WAS AVAILABLE FROM THE EVENT. THE RISK MANAGER CONFIRMED THAT THE PATIENT WAS TRANSPORTED TO WVU MEDICINE RUBY MEMORIAL IN MORGANTOWN, WEST VIRGINIA AND THEY DO NOT HAVE ANY ADDITIONAL INFORMATION ON THE BUDDY LITE AS THEY DISPOSE OF DISPOSABLES AFTER EACH FLIGHT EVEN IF THEY FAIL. NO DEVICE MALFUNCTION COULD BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT FILE WILL BE REOPENED IN THE EVENT ADDITIONAL INFORMATION BECOME AVAILABLE. WE WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT CLOSELY AND TAKE FURTHER CORRECTIVE AND PREVENTIVE ACTIONS IF REQUIRED.

Description of Event or Problem

THE MEDWATCH # MW5162494 STATED THE FOLLOWING: WHEN ATTEMPTING TO USE THE BUDDY LITE TO TRANSFUSE A HYPOTHERMIC TRAUMA PATIENT, THE CARTRIDGE WAS PLACED IN THE DEVICE AND PRIMED WITH IVF. IVF BEGAN LEAKING AFTER PRIMING. THE CARTRIDGE WAS REMOVED FROM PATIENT IV LINE AND DISCARDED. THE PATIENT WAS TRANSFUSED WITHOUT THE WARMING DEVICE BEING USED.