THE BELMONT BUDDY LITE
Received Oct 8, 2025 · Event occurred Aug 10, 2025
Report 1219702-2025-00062 · MDR key 23249192
Device
Generic name
Thermal Infusion Fluid Warmer
Manufacturer
Belmont Medical TechnologiesProduct problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BUDDY LITE WAS FOUND TO BE BROKEN. THE METAL HEATING PLATE WAS DISLODGED FROM THE HOUSING, PREVENTING THE CASE FROM BEING PROPERLY LATCHED CLOSED.
Additional Manufacturer Narrative
THE INTERNAL COMPLAINT FILE # (B)(4) HAS BEEN LOGGED FOR THIS INCIDENT FOR TRACEABILITY. THE BUDDY LITE UNIT INVOLVED IN THIS INCIDENT IS NOT YET RETURNED TO BELMONT FOR INVESTIGATION. AS PER THE MEDWATCH REPORT, THE DATE OF EVENT IS (B)(6) 2025. BELMONT BECAME AWARE OF THIS INCIDENT AFTER RECEIVING THE MEDWATCH REPORT #MW5174571 ON SEPTEMBER 9, 2025, THEREFORE SUBMITTING THIS NOW. BELMONT CONTACTED THE USER FACILITY ON SEPTEMBER 10, 2025 AND OCTOBER 1, 2025, TO COLLECT ADDITIONAL INFORMATION ON THE EVENT (S/N NUMBER OF THE DEVICE, AVAILABILITY OF THE UNIT FOR INVESTIGATION ETC.) BUT WE HAVEN'T RECEIVED ANY RESPONSE AS OF YET. THE DEVICE CANNOT BE PUT INTO USE IN THE EVENT THE HEATING PLATE IS DISLODGED. THIS IS IMMEDIATELY OBVIOUS TO THE USER WHILE ATTEMPTING TO UTILIZE THE DEVICE. ANOTHER DEVICE OR ALTERNATIVE METHODS CAN BE USED TO INFUSE THE PATIENT. BELMONT IS WORKING WITH THE USER FACILITY TO GATHER ADDITIONAL DETAILS ON THE EVENT AND GET THE DEVICE INVOLVED IN THIS INCIDENT RETURNED FOR INVESTIGATION. WITHOUT RESULTS OF THE DEVICE INVESTIGATION, NO CONCLUSIONS CAN BE DRAWN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE UNIT, IMAGES SHOWING THE REPORTED ISSUE AND A RETURN OF THE UNIT FOR INVESTIGATION WERE REQUESTED. IT WAS DETERMINED NONE OF THIS INFORMATION WAS AVAILABLE AS THE UNIT WAS DISPOSED OF. NO REVIEW COULD BE PERFORMED INTO THE DEVICE HISTORY OF THE UNIT AS THE SERIAL NUMBER WAS UNKNOWN. NO DEVICE MALFUNCTION COULD BE VERIFIED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR THIS TYPE OF INCIDENT CLOSELY AND TAKE FURTHER CORRECTIVE AND PREVENTATIVE ACTION IF REQUIRED.