BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1021537 · Received March 26, 2008

    Report

    Report Number
    1423500-2008-00188
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 14, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CONVERSATION WITH A HOME PT'S NURSE, THE NURSE REPORTED A POTENTIAL OVERFILL SITUATION. THE NURSE PROVIDED THE NUMBERS FOR THE PT'S THERAPY IN 2008: LAST FILL VOLUME WAS 1000ML; INITIAL DRAIN VOLUME 1667 ML. PER THE NURSE, THE HOME PT WAS HOSPITALIZED ON THE FOLLOWING MONTH FOR SHORTNESS OF BREATH AND CHEST PAINS WHICH SHE STATED ARE UNRELATED TO THERAPY. THE NURSE HAD NO INPUT INTO THE CAUSE OF THE POTENTIAL OVERFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1