JAPANESE, RAPID INFUSER, 100 V, 750 ML/MIN 903-00001-JRecalls & reported problems
Belmont Instrument Corporation · FLUID WARMER, 100 V SYSTEM BOXED · 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 20896128002019), received between Jul 12, 2019 and Jul 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K032674); 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
Device problems
- Electrical /Electronic Property Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND REPORTED THAT THE UNIT WAS INFUSING FOR 2 HOURS AT 150 TO 250ML/MIN DURING CARDIOVASCULAR SURGERY AND EXHIBITED A "HEATER READBACK FAULT" ALARM AT THE END OF THE PROCESS. THE UNIT CONTINUOUSLY EXHIBITED THE SAME ALARM AFTER IT WAS RESTARTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8787359 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032674. One submission often covers many models, so check the product and lot details in each record.
- Z-0058-2013 · Sep 25, 2012 · TerminatedBelmont Rapid Infuser, a Fluid Management System, Model FMS2000.
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.
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