buddy lite® Blood/Fluid Warmer 905-00017Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20896128002491), received between Jul 21, 2019 and Jan 27, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Leak/Splash

  IT WAS REPORTED THAT DURING INFUSION OF PACKED RED BLOOD CELLS (PRBCS), THE BUDDY LITE CARTRIDGE RUPTURED, RESULTING IN APPROXIMATELY 20 ML OF PRBC LOSS. THE INFUSION WAS GRAVITY-DRIVEN WITH NO PRESSURE APPLIED AT THE TIME OF THE EVENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE DEVICE ISSUE. THE CARTRIDGE WAS REMOVED, AND THE INFUSION WAS CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188429 ↗
• MalfunctionJan 15, 2021Material Rupture; Material Separation

  BELMONT'S SALES REPRESENTATIVE RECEIVED A REPORT FROM THE USER FACILITY THAT THE DISPOSABLE SET BURST INSIDE THE BUDDY LITE AND DISLODGED THE HEATING PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181317 ↗
• MalfunctionJul 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "USER WAS DELIVERING RBC AT 60ML/HOUR THROUGH THE BUDDY LITE UTILIZING THE BAXTER SIGMA IV PUMP ON A BROVIAC CATHETHER. DURING THE INFUSION, IT WAS RECOGNIZED THAT THE PRESSURE RELIEF VALVE ON THE BUDDY LITE DISPOSABLE WAS LEAKING. THE TUBING WAS REPLACED, THE INFUSION WAS CONTINUED, THE FLOW RATE WAS SET AT 50ML/HOUR AND THEN WAS RAISED UP TO 60ML/HOUR AGAIN AND THE REMAINDER OF THE 150ML OF BLOOD WAS DELIVERED TO THE PATIENT. AT THE VERY END OF THE DELIVERY, THE PRESSURE RELIEF VALVE LEAKED AGAIN. CHARLENE WILL VISIT THE FACILITY TODAY TO SEE HOW THE BUDDY LITE WAS/IS UTILIZED. THE FACILITY WAS LOOKING TO SEE IF THERE IS A WAY THAT THE BUDDY LITE CAN BE UTILIZED WITH AN IV PUMP FOR BLOOD DELIVERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8810152 ↗