THE BELMONT BUDDY LITE

Additional Manufacturer Narrative

THE INTERNAL COMPLAINT FILE # CMP- (B)(4). HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. BELMONT RECEIVED THE BUDDY LITE UNIT INVOLVED IN THE INCIDENT BACK FOR INVESTIGATION ON 04/18/2022. IT WAS CONFIRMED ON 05/02/2022. THAT THE BUDDY LITE DEVICE DID NOT INJURE THE PATIENT. WHEN THE BUDDY LITE FUNCTIONS NORMALLY, THE GREEN LED ON THE HEATER UNIT WILL BLINK WITH EACH HEATING CYCLE. AN OVER TEMPERATURE CONDITION CAUSES THE UNIT TO STOP HEATING, THE GREEN LED STOPS BLINKING, AND AN ALARM ALERT WILL BE ACTIVATED, AND THE BLUE/RED LED WILL FLASH ALTERNATELY.UNDER ALARM CONDITIONS, AN AUDIBLE ALARM IS ACTIVATED AND THE BLUE/RED LED FLASHES. ALARM CONDITIONS INCLUDE-OVER TEMPERATURE, PROBE FAULT, CHECK FOR AIR, AND NO HEAT.THE OPERATOR'S MANUAL ALSO PROVIDES POSSIBLE CONDITIONS, ADDITIONAL RECOMMENDED OPERATOR ACTIONS AND ROUTIME MAINTENANCE REQUIREMENTS.ROUTINE MAINTENANCE CONSISTS OF CLEANING AND INSPECTING THE HEATER UNIT, RECHARGE THE BATTERY AFTER EACH USE, RECALIBRATE THE BATTERY FUEL GAUGE, AND TESTING THE SYSTEM OPERATIONAL. UPON RECEIPT OF THE REFERENCED BUDDY LITE UNIT, WE WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT AFTER EXTENSIVE TESTING. THE BUDDY LITE SYSTEM PERFORMED ACCORDING TO OUR SPECIFICATIONS WITHOUT ANY PROBLEMS. THE BUDDY DISPOSABLE SET WAS NOT RETURNED TO BELMONT FOR EVALUATION. THEREFORE; A THOROUGH INVESTIGATION INTO THE DISPOSABLE SET IS NOT POSSIBLE. ALL BUDDY DISPOSABLE SETS ARE 100% VISUALLY INSPECTED AND 100% LEAK TESTED PRIOR TO FINAL PACKAGING BY BELMONT MEDICAL TECHNOLOGIES. A REVIEW OF PAST COMPLAINTS INDICATES THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE THAT HAS LEAD TO BREAKAGE OF CARTRIDGE. NO TREND HAS BEEN IDENTIFIED FOR THIS TYPE OF ISSUE. THERE IS NO KNOWN INJURY TO THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT THE BUDDY LITE WAS BEING USED VIA AN INTRAOSSEUS ACCESS POINT AND THAT THE CARTRIDGE BROKE AFTER 5 MINUTES OF USE. THE BUDDY LITE WAS DISCONTINUED AND THE REMAINING BLOOD PRODUCT WAS PUSHED UNWARMED THROUGH A NEW PERIPHERAL ACCESS POINT.