buddy™ Disposable Set (1 Piece) 905-00010PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00896128002091), received between Mar 20, 2019 and Dec 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Leak/Splash; Leak/Splash

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019272 ↗
• MalfunctionAug 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT MEDICAL TECHNOLOGIES RECEIVED USER FACILITY REPORT NUMBER (B)(4) FROM THE FDA, DESCRIBING THE FOLLOWING EVENT WHICH REPORTEDLY OCCURRED ON (B)(6)2020: "USED THE BUDDY LITE TO WARM FLUIDS (BURN PATIENT), LOADED THE CASSETTE, PRIMED THE LINE, ATTACHED IT TO THE PATIENT, AND TURNED IT ON (IVF [INTRAVENOUS FLUIDS] NOT UNDER PRESSURE, JUST WO). WHEN ON, FINALLY NOTICED FLUID LEAKING. IV LOCKED AND FLUIDS LOCKED. AFTER TRANSFER OF PT TO TRAUMA BED AND EVERYTHING SETTLED DOWN, DISCONNECTED THE BUDDY LITE FROM PT, IV WAS FLUSHED AND PATENT. BUDDYLITE DISPOSABLE SET REF 905-00010P. TUBING WAS STOPPED AND REMOVED FROM PATIENT USE. IV WAS FLUSHED WITHOUT INCIDENT AND INFUSION CONTINUED. NO DOCUMENTATION TO SUPPORT HYPOTHERMIA. ADMITTED TO ICU AND DISCHARGED, TO FOLLOW UP WITH BURN CLINIC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284920 ↗
• MalfunctionJun 25, 2021Fluid/Blood Leak

  USED THE BUDDY LITE TO WARM FLUIDS (BURN PATIENT), LOADED THE CASSETTE, PRIMED THE LINE, ATTACHED IT TO THE PATIENT, AND TURNED IT ON (IVF [INTRAVENOUS FLUIDS] NOT UNDER PRESSURE, JUST WO). WHEN ON, FINALLY NOTICED FLUID LEAKING. IV LOCKED AND FLUIDS LOCKED. AFTER TRANSFER OF PT TO TRAUMA BED AND EVERYTHING SETTLED DOWN, DISCONNECTED THE BUDDY LITE FROM PT, IV WAS FLUSHED AND PATENT. BUDDYLITE DISPOSABLE SET REF 905-00010P. TUBING WAS STOPPED AND REMOVED FROM PATIENT USE. IV WAS FLUSHED WITHOUT INCIDENT AND INFUSION CONTINUED. NO DOCUMENTATION TO SUPPORT HYPOTHERMIA. ADMITTED TO ICU AND DISCHARGED, TO FOLLOW UP WITH BURN CLINIC.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 12066171 ↗
• MalfunctionNov 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT TWO BUDDY DISPOSABLE SETS LEAKED DURING A CASE ON (B)(6)2020. BOTH SETS WERE DISCARDED BY THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906323 ↗
• MalfunctionSep 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE BIOMED REPORTED THE FOLLOWING: "ONE OF OUR FLIGHT CREWS WERE USING THE BUDDY LITE FLUID WARMER AND NOTICED THAT BLOOD COMING FROM THE WARMER PLATE AREA WHERE THE TUBING ATTACHES TO THE FLAT PORTION OF THE BLOOD WARMER TUBING. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT ONE SIDE OF THE FLAT PORTION OF THE BLOOD WARMER TUBING THAT SEATS ON THE WARMER PLATES HAD A DEFECT. THE MEMBRANE ON THE FLAT PORTION OF THE BLOOD WARMER TUBING HAD A TINY AREA THAT WAS DETACHED AT THE EDGE, WHERE THE BLOOD ENTERS THE STATED FLAT PORTION OF THE BLOOD WARMING TUBING. THE BUDDY LITE IS NOT SEALED, WHICH ALLOWED BLOOD TO GET INTO THE INNER WORKINGS OF THE DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10556374 ↗
• MalfunctionJun 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE BELMONT BUDDY DISPOSABLE SETS, THE STAFF NOTICED THAT THE SET WAS LEAKING. THE USER TESTED A NEW SET AND FOUND THAT SET WAS ALSO LEAKING FROM THE SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714351 ↗
• MalfunctionJun 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CRNA EXPERIENCED FLUID LEAKING FROM THE PRESSURE RELEASE VALVE ON THE BUDDY DISPOSABLE SET.

  Patient problems: No Information

  MAUDE report 8680845 ↗
• MalfunctionMar 20, 2019Crack; Fluid/Blood Leak; Melted

  CRITICAL PATIENT BEING AIRLIFTED TO HEALTHCARE FACILITY. DURING TRANSPORT, WHEN THE NURSE WAS HANGING THE FIRST UNIT OF BLOOD, THE BUDDY LITE TUBING CRACKED AFTER BLOOD WAS PRIMED THROUGH THE BUDDY LITE UNIT. BECAUSE THE LEAKING BLOOD WAS HIGHLY VISIBLE, THERE WAS MINIMAL BLOOD LOST FROM THE UNIT. NEW BUDDY LITE TUBING WAS PLACED AND THE TRANSFUSION CONTINUED WITHOUT FURTHER DELAY/ISSUES. THIS IS THE EIGHTH REPORTED EVENT INVOLVING CRACKED BUDDY LITE TUBING THAT HAS OCCURRED IN 2017. THE FIRST FOUR EVENTS WERE REPORTED VIA VOLUNTARY REPORTS. EVENT #5: DURING AIR TRANSPORT, A BUDDY LITE CASSETTE LEAKED BLOOD DURING BLOOD TRANSFUSION. THERE WAS NO HARM TO PATIENT BECAUSE OF ACTIVE RECOVERY BY STAFF. EVENT #6: DURING AIR TRANSPORT, A UNIT OF PACKED RED BLOOD CELLS WERE BEING ADMINISTERED WITH THE BUDDY LITE BLOOD WARMER. AFTER 10 TO 15 MINUTES OF INFUSING, THERE WAS BLOOD DRAINING OUT OF THE HEATING ELEMENT. IT APPEARED THAT THE INSERT THAT GOES INSIDE THE WARMER MELTED/RUPTURED. THE INFUSION WAS DISCONTINUED DUE TO MEMBRANE RUPTURE. NO HARM TO PATIENT. EVENT #7: DURING AIR TRANSPORT, ONE UNIT OF PACKED RED BLOOD CELLS WAS BEING ADMINISTERED USING THE INLINE BLOOD WARMER. THE FLUID WA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8435882 ↗