buddy lite AC Blood/Fluid Warmer 905-00022Recalls & reported problems
Belmont Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10896128002449), received between May 18, 2019 and May 14, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Smoking” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Smoking2
- Sparking2
- Electrical Shorting1
- Excessive Heating1
- Leak/Splash1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2021Smoking; Sparking; Smoking; Sparking
BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING MEDWATCH REPORT (UF/IMPORTER REPORT # (B)(4)) FROM THE DEPARTMENT OF HEALTH & HUMAN SERVICES: "THE AC ADAPTER OF THE BELMONT BUDDY LITE FLUID WARMER BECAME WET WITH BLOOD. WHILE TRYING TO CLEAN THE DEVICE, THE USER USED CAVICIDE AND SPRAYED THE AC ADAPTER WITHOUT UNPLUGGING IT FROM THE ELECTRICAL OUTLET, CAUSING A SHORT CIRCUIT ON THE POWER SUPPLY THAT GENERATED SPARKS AND SMOKE IN THE OPERATING ROOM (OR). THE OR PROCEDURE WAS ALREADY COMPLETED AT THE TIME OF THE INCIDENT, NO PATIENT OR USER WERE HARMED BY THIS SITUATION. THE AC ADAPTER AND BELMONT BUDDY LITE WERE REMOVED FROM SERVICE. OR LEADERSHIP CONDUCTED A PROCEDURE REVIEW WITH OR PERSONNEL TO REVIEW PROPER CLEANING PROCEDURES OF EQUIPMENT THAT ARE CONTAMINATED WITH BIOLOGICAL FLUIDS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11829429 ↗MalfunctionApr 5, 2021Leak/Splash; Smoking; Sparking; Electrical Shorting
THE AC ADAPTER OF THE BELMONT BUDDY LITE FLUID WARMER BECAME WET WITH BLOOD. WHILE TRYING TO CLEAN THE DEVICE, THE USER USED CAVICIDE AND SPRAYED THE AC ADAPTER WITHOUT UNPLUGGING IT FROM THE ELECTRICAL OUTLET, CAUSING A SHORT CIRCUIT ON THE POWER SUPPLY THAT GENERATED SPARKS AND SMOKE IN THE OPERATING ROOM (OR). THE OPERATING ROOM PROCEDURE WAS ALREADY COMPLETED AT THE TIME OF THE INCIDENT, NO PATIENT OR USER WERE HARMED BY THIS SITUATION. THE AC ADAPTER AND BELMONT BUDDY LITE WERE REMOVED FROM SERVICE. OPERATING ROOM LEADERSHIP CONDUCTED A PROCEDURE REVIEW WITH OPERATING ROOM PERSONNEL TO REVIEW PROPER CLEANING PROCEDURES OF EQUIPMENT THAT ARE CONTAMINATED WITH BIOLOGICAL FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11612730 ↗MalfunctionJun 14, 2019Temperature Problem; Temperature Problem
BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "THERE WAS ANOTHER FIRE WITH THE BUDDY LIGHT TONIGHT, IN ANOTHER OR. I QUESTIONED THE COMMENT AND RECEIVED BACK ON THE 16TH 'GOOD AFTERNOON, ATRIUM IS PERFORMING A RISK ASSESSMENT ON THE EVENT. I BELIEVE THE UNIT IS WITH GE/BIOMED. I AM AWAITING THEIR REVIEW MYSELF.'
Patient problems: No Information
MAUDE report 8701497 ↗MalfunctionMay 18, 2019Excessive Heating; Excessive Heating
THE USER FACILITY REPORTED THAT THE BUDDY LITE AC CARTRIDGE OVERHEATED.
Patient problems: No Information
MAUDE report 8622419 ↗
Other Warmer, Blood, Non-Electromagnetic Radiation devices
- Level 1 8002950Icu Medical, Inc. · Warmer, blood, non-electromagnetic radiation10 deaths931 reports
- Ranger™ 243553m Company · Warmer, blood, non-electromagnetic radiation107 reports
- 3M™ Ranger™ 243553m Company · Warmer, blood, non-electromagnetic radiation64 reports
- Ranger™ 243703m Company · Warmer, blood, non-electromagnetic radiation38 reports
- Ranger™ 243653m Company · Warmer, blood, non-electromagnetic radiation16 reports
- 3M™ Ranger™ 243703m Company · Warmer, blood, non-electromagnetic radiation9 reports
- buddy™ Disposable Set (1 Piece) 905-00010PBelmont Instrument Corporation · Warmer, Blood, Non-Electromagnetic Radiation8 reports
- Ranger™ 243553m Company · Warmer, blood, non-electromagnetic radiation6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page