BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER REFURBISHED

    MDR report key: 1009646 · Received March 6, 2008

    Report

    Report Number
    1423500-2008-00137
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510K #: K923065.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SVC CTR TO REQUEST ASSISTANCE REPRIMING THE PT LINE WITH THE HOMECHOICE (HC) MACHINE. THE TECH SVC REP (TSR) EXPLAINED THE REPRIME PROCEDURE TO THE CAREGIVER (CG). THE CG STATES THAT SHE REVIEWS THE THERAPY LOG EVERY NIGHT AND THE HOME PT (HP) HAS A TOTAL VOLUME OF 3300 ML. ACCORDING TO THE CG, THE THERAPY LOG FROM TWO NIGHTS AGO INDICATED THE TOTAL FILL VOLUME WAS 3498 ML. ACCORDING TO THE CG, THE HP IS ALSO GETTING A LAST FILL VOLUME SOMETIMES OF 10 OR 15 ML WHEN HER PROGRAMMED LAST FILL IS 0 ML. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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