German, Rapid Infuser RI-2, 230V, 1000 ml/min 903-00037A-GRecalls & 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 40896128002754), received between Sep 20, 2019 and Mar 21, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Conduct” (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
- Failure to Conduct1
- Insufficient Device Problem Information1
- Output Problem1
- Temperature Problem1
Patient problems
- No Information2
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WITH HEMORRHAGIC SHOCK SHOULD BE TREATED WITH THE RAPID INFUSION DEVICE. AFTER PRESSING THE SOFTKEYS "FULLEN" ON THE SCREEN WILL RESTART THE DEVICE AGAIN AND AGAIN UP TO THIS POINT. THE TREATMENT HAD TO BE CARRIED OUT WITH AN IDENTICAL REPLACEMENT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665446 ↗MalfunctionSep 2, 2020Failure to Conduct; Failure to Conduct
BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT, "DEVICE WAS ATTACHED TO THREE DIFFERENT SOCKETS AND THE FUSE WAS ALWAYS BLOWN. CABLE WAS CHECKED BY THE TECHNICAL SERVICE, BUT SHOWED NO DEFICITS."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10484811 ↗MalfunctionOct 1, 2019Output Problem; Output Problem
IT WAS REPORTED THAT THE RAPID INFUSER EXHIBITED A "VALVE FAULT" ALARM (SYSTEM ERROR #208), AND THAT THERE WERE DOUBLE IMAGES ON THE DISPLAY. OUR DISTRIBUTOR RELAYED THE FOLLOWING REPORT: "THE CUSTOMER INFORMED US THAT THE SYSTEM HAS PRODUCED THE ERROR CODE 208 DURING NORMAL USE. THE ERROR SHOWED UP AFTER 2 HOURS AND CAN NOT BE RESET. IT SEEMS TO BE A PERMANENT PROBLEM NOW."
Patient problems: No Information
MAUDE report 9142823 ↗MalfunctionSep 20, 2019Temperature Problem; Temperature Problem
OUR DISTRIBUTOR REPORTED THAT THE RAPID INFUSER EXHIBITED AN "OVER TEMPERATURE" ALARM.
Patient problems: No Information
MAUDE report 9101151 ↗
Other Warmer, Thermal, Infusion Fluid devices
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- 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.
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