BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1051220 · Received May 23, 2008

    Report

    Report Number
    1423500-2008-00399
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 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).

    Description of Event or Problem · 1

    THE WIFE OF THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REP (TSR) AND REPORTED THE HP FELT ABDOMINAL DISCOMFORT, AS IF HE WERE OVERFILLED WITH FLUID, AT THE END OF THE THERAPY USING THE HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HP EXPERIENCED DIFFICULTY DRAINING DURING THE APD THERAPY AND PERFORMED A POST APD THERAPY MANUAL EXCHANGE, REMOVING 2100MLS OF FLUID. REVIEW OF THE CYCLER'S THERAPY LOG REVEALED THE HP HAD A TOTAL ULTRAFILTRATION (UF) VOLUME OF - 968MLS FOR THE APD THERAPY AND 2 BYPASSES HAD BEEN PERFORMED. THE APD CYCLER WAS PROGRAMMED FOR 5 CYCLES OF 2100MLS WITH AN ADD'L LAST FILL OF 200MLS AND WAS POSITIONED 2 FEET ABOVE THE HP. THE TSR EXPLAINED THE MINIMUM DRAIN VOLUME PERCENTAGE OF 85% PER CYCLE AND REVIEWED THE CYCLE BY CYCLE UF VOLUMES WITH THE CALLER, WHICH REVEALED THE HP HAD DRAINED OUT AT LEAST 85% OR MORE OF THE PROGRAMMED FILL VOLUME OF 2100MLS DURING EACH COMPLETED CYCLE. THE TSR EXPLAINED TO THE CALLER THAT WHEN THE HP HAD PERFORMED THE MANUAL DRAIN POST APD THERAPY HE REMOVED THE LAST FILL VOLUME OF 200MLS PLUS THE RESIDUAL UF VOLUME OF -968MLS. THE TSR EXPLAINED THAT THE CYCLER WAS POSITIONED TOO HIGH ABOVE THE HP AND INSTRUCTED THE CALLER TO LOWER THE HEIGHT OF THE CYCLER. THE TSR SUBSEQUENTLY SWAPPED THE CUSTOMER'S DEVICE. THERE WAS NO PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1