BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1082132 · Received July 25, 2008

    Report

    Report Number
    1423500-2008-00688
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE HOME PT DID NOT WISH TO RETURN HIS HOMECHOICE MACHINE FOR EVAL.

    Description of Event or Problem · 1

    THE HOME PT (HP) CONTACTED BAXTER TECHNICAL SVS ON 07/08/2008 AND REPORTED FEELING OVERFILLED DURING HIS PREVIOUS THERAPY (THERAPY ON (B) (6) 2008). BAXTER PROD SURVEILLANCE PLACED A F/U CALL TO THE HP TO OBTAIN ADD'L DETAIL AND HE DID NOT RECALL THIS ISSUE. HE STATED THAT HE HAS DIFFICULTY DRAINING AT TIMES. HE REPORTED HE HAS HAD A "GOOD DRAIN VOLUME" OF 3200 ML IN THE PAST. THE HOME PT'S PROGRAMMED FILL VOLUME IS 2000 ML. HE STATED HE IS FEELING FINE AND THERAPY IS GOING WELL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS 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