enFlow 980202EURecalls & reported problems
Carefusion Corporation · enFlow™ Disposable IV Fluid/Blood Warmer Cartridge With IV Extension Model 200 · Class 2
- 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 10885403286162), received between Mar 14, 2019 and Mar 14, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Particulates” (3 reports).
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
- Particulates3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2019Particulates; Particulates
A NEWS ARTICLE BY THE BMJ TITLED "ENFLOW FLUID WARMING DEVICE: WARNING OVER RISK OF ALUMINIUM TOXICITY" WAS PUBLISHED ON MARCH 11, 2019. THE ARTICLE MENTIONS A RECENT PAPER IN ANAESTHESIA THAT UNCOATED ALUMINIUM PLATES IN FLUID WARMING SYSTEMS, SUCH AS THOSE USED IN THE ENFLOW SYSTEM, YIELDED POTENTIALLY HARMFUL CONCENTRATIONS OF ALUMINIUM WHEN USING BALANCED ELECTROLYTE SOLUTIONS. LEAD RESEARCHER THORSTEN PERL, SENIOR CONSULTANT AT THE UNIVERSITY MEDICAL CENTRE (B)(6), TOLD THE BMJ THAT PATIENTS WITH IMPAIRED ALUMINIUM ELIMINATION FROM RENAL INSUFFICIENCY WERE AT RISK OF ADVERSE EVENTS. "AN EFFECTIVE COATING FOR ALUMINIUM CONTAINING MEDICAL DEVICES IN DIRECT CONTACT WITH FLUIDS SHOULD BE RECOMMENDED," HE SAID.
Patient problems: No Patient Involvement
MAUDE report 8423041 ↗MalfunctionMar 14, 2019Particulates; Particulates
AN ARTICLE PUBLISHED BY ANAESTHESIA JOURNAL ON (B)(6) 2019 SUGGESTS THAT USING UNCOATED ALUMINIUM PLATES IN FLUID-WARMING SYSTEMS, SUCH AS WITH THE ENFLOW IV FLUID/BLOOD WARMING DEVICE, CAN LEAD TO A RISK OF ADMINISTERING POTENTIALLY HARMFUL CONCENTRATIONS OF ALUMINIUM WHEN BALANCED CRYSTALLOID SOLUTIONS ARE USED.
Patient problems: No Patient Involvement
MAUDE report 8423038 ↗MalfunctionMar 14, 2019Particulates; Particulates
AFTER BEING ALERTED TO POSSIBLY HIGH LEVELS OF ALUMINIUM BEING RELEASED INTO INFUSATE AFTER USE OF THE ENFLOW CARTRIDGE VIA GUARDIAN ARTICLE AND ANAESTHESIA PAPER, (B)(6) HOSPITAL ELECTED TO CONDUCT THEIR OWN BENCH TESTING USING SALINE AND PLASMALYTE (BAXTER). SAMPLES WERE COLLECTED USING NO-TOUCH TECHNIQUE. SAMPLES SENT TO A LOCAL LAB (LABPLUS) FOR TRACE ELEMENT (ALUMINIUM) TESTING (TESTING PROTOCOL UNKNOWN). BASED ON THE RESULTS THEY FIND THE ALUMINIUM LEVELS UNREASONABLY HIGH AND ARE NOT USING THE ENFLOW ON ANY PATIENTS UNTIL A SUITABLE ALTERNATIVE IS FOUND.
Patient problems: No Patient Involvement
MAUDE report 8423025 ↗
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- 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.