BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1045430 · Received May 13, 2008

    Report

    Report Number
    1423500-2008-00334
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) NUMBER: K923065.

    Description of Event or Problem · 1

    THE HOME PT (HP) CONTACTED A TECHNICAL SERVICE REP (TSR) AND REPORTED EXPERIENCING ABDOMINAL BLOATING, AS IF SHE WERE OVERFILLED WITH FLUID, DURING DWELL 3 OF 5 USING THE HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHO VERBALLY ASSISTED THE HP TO PERFORM A MANUAL DRAIN. DURING THE MANUAL DRAIN 3471 MLS OF FLUID WAS REMOVED, WHICH WAS 1371 MLS MORE THAN THE PROGRAMMED FILL VOLUME OF 2100 MLS. THE TSR ASSISTED THE HP TO END THE THERAPY EARLY AND THE TOTAL ULTRAFILTRATION VOLUME WAS 1021MLS. THE TSR SUBSEQUENTLY SWAPPED THE HP'S CYCLER. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORTED INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1