BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS

    MDR report key: 4231900 · Received October 17, 2014

    Report

    Report Number
    2016945-2014-00002
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CODAN US CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PRIOR TO DECONTAMINATION INDICATED YELLOWISH CRUSTY SUBSTANCE IN THE VALVE PREVENTING THE CHECK VALVE FROM CLOSING COMPLETELY. APPEARED THE VALVE WAS NOT FLUSHED AFTER DISCONNECT OF OTHER UNK IV SET THAT BLOOD HAD BEEN INFUSED THROUGH. UPON DECONTAMINATION OF THE EVENT UNIT, WHEN TESTED WORKED PROPERLY INDICATING USER ERROR.

    Description of Event or Problem · 1

    DURING TRANSPORT TO THE ICU THE PT BEGAN WAKING UP AND BECOMING HYPERTENSIVE, THE M.D. GAVE SEDATION THROUGH THE MANIFOLD, THE VALVE NEXT TO THE ONE USE FOR THE INJECTION STARTED LEAKING. DURING THE CASE, 1300CC OF BLOOD WERE GIVEN THROUGH THE MANIFOLD. THE CURRENT LOT NUMBER FROM THE LEAK IS 77072.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662499 WALRUS EXTENSION SET FPA CODAN US CORP. 72.7945 77072

    Patients

    Seq Age Sex Outcome Treatment
    1 Other