BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1071535 · Received July 3, 2008

    Report

    Report Number
    1423500-2008-00603
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 15, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    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 TO BAXTER.

    Description of Event or Problem · 1

    A HOME PT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT AN OVERFILL WITH THE HOMECHOICE (HC) MACHINE. THE HP REPORTED THAT THE PREVIOUS DAY, HE HAD A DRAIN VOLUME OF 3000 ML. THE TECHNICAL SERVICE REP (TSR) ADVISED THE HP THAT HE WOULD NEED TO CALL BACK AT THE END OF THERAPY TO REVIEW THE DATA (HP WAS IN DWELL 3 OF 5 OF CURRENT THERAPY AND REPORTING ABOUT AN OVERFILL FROM THE PREVIOUS THERAPY SESSION). THE HP CALLED BACK AND REVIEWED THE PROGRAM INFO. THIS PT'S PROGRAMMED FILL VOLUME IS 2000 ML. THE MACHINE RECORDED 9 BYPASSES HAD BEEN PERFORMED DURING THERAPY. THE HP HAD NO IDEA WHAT HE BYPASSED. THE TSR ADVISED THE HP NOT TO BYPASS WITHOUT ASSISTANCE. ADDITIONALLY THE TSR SUGGESTED THE HP CALL HIS NURSE TO RAISE THE MINIMUM DRAIN PERCENTAGE FOR THERAPY IN THE NURSE'S MENU. PRODUCT SURVEILLANCE SPOKE WITH THE HOME PT'S NURSE REGARDING THIS ISSUE. SHE STATED THAT THE HOME PT HAD MADE HER AWARE OF THE PROBLEMS HE HAD WITH OVERFILL, AND SHE REQUESTED EXPLANATION OF THE MINIMUM DRAIN VOLUME PERCENTAGE SETTING. PRODUCT SURVEILLANCE EXPLAINED THE SETTING AND THE NURSE UNDERSTOOD. SHE WILL REVIEW THE PT'S THERAPY SETTINGS AND ADJUST AS APPROPRIATE. ADDITIONALLY, THE NURSE REPORTED THAT SHE INSTRUCTS HER PTS NOT TO BYPASS AND APPRECIATED BEING NOTIFIED THAT THIS PT WAS BYPASSING DURING THERAPY. SHE WILL ADVISE HIM NOT TO BYPASS WITHOUT ASSISTANCE. 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 78 YR