UK, Rapid Infuser RI-2, 230V, 1000 ml/min 903-00037A-UKRecalls & reported problems
Belmont Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896128002800), received between Jun 11, 2021 and Feb 20, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- No Tactile Prompts/Feedback1
- No Visual Prompts/Feedback1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE RI-2 WAS SET UP FOR USE IN AN EMERGENCY AND PRIMED WITH SALINE. AFTER APPROXIMATELY 30 SECONDS, THE DEVICE DISPLAYED AN UNSPECIFIED ERROR MESSAGE. THE SYSTEM WAS POWERED OFF AND THEN RESTARTED. FOLLOWING RESTART, BLOOD PRODUCTS WERE INFUSED FOR APPROXIMATELY 10-15 MINUTES. THE PATIENT LATER DIED; HOWEVER, IT WAS CONFIRMED THAT THE PATIENT DEATH WAS NOT RELATED TO THE RI-2 SYSTEM OR THE DISPOSABLE SET.
Patient problems: Insufficient Information
MAUDE report 24405827 ↗MalfunctionJun 11, 2021No Visual Prompts/Feedback; No Tactile Prompts/Feedback; No Visual Prompts/Feedback; No Tactile Prompts/Feedback
BELMONT MEDICAL TECHNOLOGIES RECEIVED THE FOLLOWING REPORT (REPORT NUMBER: 2021/004/029/291/013) FROM THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) IN THE UK: "INFRARENAL AAA REPAIR. BELMONT RI-2 (1000ML/MIN VERSION) HAD BEEN WORKING FINE THROUGHOUT CASE. GRAFT IN SITU, LEGS REPERFUSED. SURGEONS DEALING WITH HAEMOSTASIS. SLOW OOZE FROM MULTIPLE SITES. FLUID AT 20ML/MIN VIA BELMONT. SLIGHT DROP IN BP, ATTEMPTED TO GIVE 200ML RAPID BOLUS BUT NO RESPONSE FROM BELMONT SCREEN. REGARDLESS OF BUTTON PRESSED, 20ML/MIN DISPLAYED. SCREEN BEEPED WHEN PRESS BUT NO APPARENT ACTION. ODP HELP REQUESTED BUT RAPID PRECIPITOUS DROP IN BP TO 60 SYSTOLIC. SURGEON MANUALLY CLAMPED AORTIC GRAFT WHILST FLUID RESUSCITATION GIVEN VIA ALTERNATIVE CANNULA AND VASOPRESSOR GIVEN. AFTER 2 X OFF/ON CYCLES BELMONT BECAME USABLE AGAIN. FURTHER EPISODE 10 MINUTES LATER. THIS TIME MORE CLEAR THAT BELMONT ACTUALLY RESPONDING TO SCREEN PRESSES, BUT DISPLAY TOTALLY FROZEN SO NO WAY TO CONFIRM CURRENT INFUSION RATE, PRESSURE ETC."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11988151 ↗
Other Warmer, Thermal, Infusion Fluid devices
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
- 3-Spike Disposable Set (1 Piece) 903-00006PBelmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall1 death97 reports
- Rapid Infuser RI-2, 120V, 750 ml/min 903-00039Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid132 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Rapid Infuser RI-2, 120V, 1000ml/min 903-00037Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 death76 reports
- Hyperthermia Pump Procedure Kit 902-00045Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall4 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