enFlow 980105VSRecalls & reported problems
Carefusion Corporation · enFlow™ IV Fluid/Blood Warmer Model 100 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403296789), received between Mar 28, 2019 and Apr 22, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Heating” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Heating1
- Signal Artifact/Noise1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2019Signal Artifact/Noise; Signal Artifact/Noise
THE CUSTOMER REPORTED WHILE USING THE ENFLOW DEVICE, THE CARDIAC ELECTROCARDIOGRAM (ECG) DISPLAYED INTERFERENCE. THE ANESTHESIOLOGIST WITNESSED WHEN THE ENFLOW MACHINE WAS TURNED ON. THE CUSTOMER REPORTED THE CASE WAS CANCELLED AND THE PATIENT WAS ORDERED A 12-LEAD ECG, WHICH CAME BACK NORMAL. THE CUSTOMER REPORTED A DELAY IN TREATMENT AND REPORTED THERE IS NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8536418 ↗InjuryMar 28, 2019Insufficient Heating; Insufficient Heating
THE CUSTOMER REPORTED WHILE USING THE ENFLOW IV FLUID/BLOOD WARMER MODEL 100; THE DEVICE IS NOT WARMING OR DELIVERING DESIRED TEMPERATURE AS INTENDED. THE ISSUE OCCURRED DURING PATIENT-USE; THE PATIENT WAS WARMED WITH ONE MACHINE IN PRE OP - TEMPERATURE WAS 36.6. THE CUSTOMER REPORTED THE PATIENT RECEIVED WARMED FLUID IN THE OPERATING ROOM - TEMPERATURE WAS 35.5 IN THE MIDDLE AND END OF THE SURGERY. THE CUSTOMER REPORTED THE TEMPERATURE IN THE OR WERE TAKEN WITH A DISPOSABLE GAS MACHINE PROBE AND THE FLUID WAS WARM TO THE TOUCH THAT WAS INFUSED INTO THE PATIENT IN THE OR. (THE IV TUBE WAS TOUCHED BY STAFF). THE CUSTOMER REPORTED ENTIRE SYSTEM IS AVAILABLE TO BE RETURNED FOR ANALYSIS (CONTROLLER/POWER SUPPLY AND BLOOD WARMER IN ORDER TO DIAGNOSE WHICH PART IS MALFUNCTIONING). THE CUSTOMER REPORTED THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8461330 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.