3-Spike Disposable Set 903-00006Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10896128002029), received between Aug 31, 2023 and Sep 23, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K242735); they may or may not involve this specific model.

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.

• MalfunctionSep 23, 2026Excessive Heating

  It was reported by the user facility that during a liver transplant procedure, the Belmont Rapid Infuser RI-2 displayed System Error #102. The error message instructed the user to discard the disposable and blood, restart the system with a new disposable, and service the device if the error persisted. The unit was also reported to be unusually hot to the touch.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867025 ↗
• MalfunctionApr 23, 2026Crack

  IT WAS REPORTED THAT THE ICU TEAM RESPONDED TO A RAPID RESPONSE EVENT TO INITIATE A MASSIVE TRANSFUSION PROTOCOL (MTP) ON A MEDICAL-SURGICAL UNIT. DURING PRIMING OF THE BELMONT TUBING SET, A CRACK WAS IDENTIFIED AT THE WHITE CONNECTOR PROXIMAL TO THE DRIP CHAMBER, RESULTING IN FLUID LEAKAGE. THE DISPOSABLE SET WAS REPLACED TO COMPLETE THE TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966893 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, WHILE REMOVING THE DISPOSABLE SET, STAFF OBSERVED BLOOD STAINING AROUND THE RIGHT SIDE OF THE HEAT EXCHANGER. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A DIFFERENT MEDICAL CARE AND LATER EXPIRED. THE PATIENT DEATH WAS UNRELATED TO THE RI-2. THE BIOMED WILL CLEAN THE UNIT AND PERFORM FUNCTIONAL TESTING; RESULTS WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188418 ↗
• MalfunctionFeb 6, 2025Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  BELMONT RECEIVED MIR REPORT ON 1/7/2025. DETAILING THE FOLLOWING. BELMONT RAPID INFUSER GIVING SET USED TO INFUSE APPROXIMATELY 40 UNITS OF BLOOD PRODUCTS, TOWARDS THE END OF USE THE GIVING SET CAME APART AT TWO OF THE THREE BAG SPIKES ON THE INFUSION LINE. BELMONT HAS RECEIVED CONFIRMATION THAT THERE WAS NO IMPACT / HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322631 ↗
• MalfunctionJan 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON ABOUT 14 OCCASIONS IN THE PAST 6 MONTHS, BLEEDING PATENTS TRANSFUSED WITH BELMONT HAVE HAD SUDDEN STRONG DROP IN BLOOD PRESSURE AND IN ABOUT 3 PATIENTS ALSO URTICARIA AND IN ONE PATIENT SWELLING OF THE THROAT. IN ALL CASES, PLASMA HAS BEEN TRANSFUSED.

  Patient problems: Anaphylactoid / Anaphylaxis

  MAUDE report 21193220 ↗
• MalfunctionJan 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RISK MANAGER REPORTED THAT WHILE USING THE BELMONT FOR RAPID TRANSFUSION, THE TUBING WAS INSERTED AND WAS LEAKING. THIS DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SET, AND THEN WORKED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481170 ↗
• MalfunctionOct 13, 2023Connection Problem; Connection Problem

  DURING MASSIVE TRANSFUSION, THE BELMONT TUBING REPORTEDLY "FELL APART" STAFF REPORTED. "THE SPIKE OF THE TUBING CAME OFF OF THE TUBING" AND "THE TUBING WAS NOT ABLE TO BE PUT BACK TOGETHER." A NEW TUBING SET-UP HAD TO BE PERFORMED DURING EMERGENT RESUSCITATION AND TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931186 ↗
• MalfunctionAug 31, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IN ANESTHESIOLOGY, A BLOOD LEAK WAS OBSERVED AT THE LEVEL OF THE JOINT OF THE HEATING CIRCLE, LEADING TO THE RISK OF HEMORRHAGE AND GAS EMBOLISM. NO CLINICAL CONSEQUENCES HAVE BEEN REPORTED. THIS INCIDENT SEEMS TO HAVE ALREADY OCCURRED WITH ANOTHER BATCH BUT HAS NOT BEEN DECLARED. WE REMINDED CAREGIVERS OF THE IMPORTANCE OF DECLARING ANY INCIDENT OR RISK OF INCIDENT IN LINK WITH THE USE OF MEDICAL DEVICES A STATEMENT HAS BEEN SENT TO ANSM (NATIONAL AGENCY FOR THE SAFETY OF MEDICINE AND HEALTH PRODUCTS) . THE INCRIMINATED DEVICE WILL NOT BE AVAILABLE AT THE PHARMACY FOR THE EXPERTISE BECAUSE SOILED AND DIFFICULT TO CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665926 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K242735. One submission often covers many models, so check the product and lot details in each record.

• Z-1678-2025 · Mar 31, 2025 · Open, Classified
  3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (
• Z-1099-2025 · Jan 2, 2025 · Open, Classified
  Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warm