Dutch, Rapid Infuser RI-2, 230V, 750 ml/min 903-00039A-DRecalls & reported problems
Belmont Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20896128002774), received between Aug 15, 2019 and Sep 5, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device1
- Display or Visual Feedback Problem1
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2024Air/Gas in Device; Air/Gas in Device
THE USER REPORTED THE FOLLOWING TO THE DANISH MEDICINES AGENCY. BELMONT MACHINE IS ALWAYS ASSEMBLED IN ADVANCE BY A TRAUMA NURSE. THE MACHINE IS THEREFORE ASSEMBLED UPON THE PT'S ARRIVAL. THE BELMONT BOWL FILLS WITH BLOOD, THE BELMONT SWITCHED ON AND PRIMED. HOSE TO THE PATIENT. TRYING TO START TRANSFUSION OF PATIENT, BUT THE MACHINE CONTINUOUSLY DISPLAYS AN ERROR SOURCE: AIR IN THE HOSE. THE HOSE PRIMED X 3 BY UT, WITHOUT LUCK. TRIED TO CHANGE BELMONT MACHINE WITH SAME SET OF HOSES, BUT THIS ALSO SHOWS AIR IN THE HOSE. NO AIR IS OBSERVED IN THE HOSE. TRANSFUSION SET TUBING IS CHANGED. THERE IS NO PATIENT INJURY ASSOCIATED WITH THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150984 ↗MalfunctionOct 7, 2020Erratic or Intermittent Display; Erratic or Intermittent Display
BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY THAT THE BOLUS SETTING OF A RAPID INFUSER, RI-2 WAS CHANGING SPONTANEOUSLY DURING A CASE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE INCIDENT. THE MEDICAL TECHNICAL ENGINEER AT THE HOSPITAL SUBSEQUENTLY TESTED THE RI-2, AND WAS UNABLE TO REPRODUCE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10646266 ↗MalfunctionAug 15, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "THIS RI-2 WAS USED DURING PATIENT CASE. FLOW RATE CHANGED WITHOUT TOUCHING THE SCREEN FROM 50 TO 60 ML/MIN AND FROM 60 TO 50 ML/MIN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8899003 ↗
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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