Norwegian, Rapid Infuser RI-2, 230V, 1000 ml/min 903-00037A-NRecalls & reported problems
Belmont Instrument Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00896128002893), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.
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
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2024Air/Gas in Device; Air/Gas in Device
THE NORWAY DISTRIBUTOR REPORTED THAT THEY HAVE HAD TWO INCIDENTS (SAME PATIENT) WHERE AIR BUBBLES (?) OCCURRED IN THE SETS DURING TRANSFUSION. THE PATIENT WAS TRANSFUSED WITH RESPECTIVELY 9 SAG + 9 PLASMA THE FIRST TIME AND THE SECOND TIME ONLY A FEW BAGS BEFORE THE SAME TENDENCY FOR AIR BUBBLES IN THE PATIENT'S TUBE WERE DISCOVERED (AGAIN). THE SETS WERE FILLED ACCORDING TO THE GUIDELINES WITH NACL AND THE CONNECTIONS WERE CHECKED BEFOREHAND. THE MAXIMUM SPEED IS REPORTEDLY 80 ML/MIN, WITH A SOMEWHAT LOWER SPEED IN BETWEEN. THERE HAVE BEEN NO ALARMS ALONG THE WAY. IT WAS SUSPECT THAT THE AIR WAS DISSOLVED IN THE BLOOD AS IT IS SUCKED/DRAINED FROM THE BAG AND THAT THE BUBBLES WERE SO SMALL THAT IT DID NOT TRIGGER AN AIR ALARM, SO THAT THE BUBBLES COLLECT IN THE PATIENT TUBE AND BECOME LARGER/MORE VISIBLE. THE PATIENT HAS HAD A CT SCAN BETWEEN OPERATIONS AND AIR WAS DETECTED IN MANY PLACES IN THE VENOUS SYSTEM.
Patient problems: Insufficient Information
MAUDE report 18956693 ↗
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- 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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