BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFLOW

    MDR report key: 8423033 · Received March 14, 2019

    Report

    Report Number
    2050001-2019-00022
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 12, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    LGZ
    UDI-DI
    10885403286155
    PMA / PMN Number
    K130867
    Removal / Correction Number
    3008959444-3/13/19-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). A RECENTLY CONDUCTED INTERNAL TESTING WITH THE RESULTS RECEIVED BY VYAIRE MEDICAL ON 11 MARCH 2019 INDICATES THAT THERE IS THE POTENTIAL TO ELUDE ALUMINUM FROM THE ENFLOW DISPOSABLE CARTRIDGE DURING INTRAVENOUS WARMING THERAPY WITH FLUID AND BLOOD SOLUTIONS. AS A RESULT, VYAIRE IS INITIATING AN IMMEDIATE GLOBAL RECALL OF THE ENFLOW DISPOSABLE CARTRIDGES PART NUMBER 980200EU & 980202EU. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER OR THROUGH VYAIRE'S INTERNAL INVESTIGATION WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214815 ENFLOW ENFLOW DISPOSABLE IV FLUID/BLOOD WARMER CARTRIDGE MODEL 200 LGZ VYAIRE MEDICAL 980200EU 10885403286155

    Patients

    Seq Age Sex Outcome Treatment
    1