BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1112737 · Received August 11, 2008

    Report

    Report Number
    1423500-2008-00738
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 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).

    Description of Event or Problem · 1

    THE HOME PT (HP) CONTACTED A TECHNICAL SERVICE REP (TSR) AND REPORTED ABDOMINAL DISCOMFORT AND DISTENTION, AS IF HE WERE OVERFILLED WITH FLUID, DURING DWELL 1 USING THE HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HP PERFORMED A MANUAL EXCHANGE AT THE HOSPITAL PRIOR TO THE START OF APD THERAPY AND WAS FILLED WITH 2000MLS. THE HP SUBSEQUENTLY STARTED APD THERAPY AND 28MLS WAS DRAINED DURING THE INITIAL DRAIN WHEN THE CYCLER ADVANCED INTO FILL 1. THE HP RECEIVED THE PROGRAMMED FILL VOLUME OF 2000MLS AND FELT BLOATED AND OVERFILLED WITH FLUID. THE TSR VERBALLY ASSISTED THE HP TO PERFORM A MANUAL DRAIN WITH THE CYCLER AND 3736MLS OF FLUID WAS REMOVED, WHICH WAS 1736MLS GREATER THAN THE PROGRAMMED FILL VOLUME OF 2000MLS. ACCORDING TO THE HP, THE CYCLER'S INITIAL DRAIN ALARM SETPOINT WAS PROGRAMMED FOR 0MLS. THE HP WANTED TO END APD THERAPY FOR THE NIGHT AND THE TSR ASSISTED THE HP TO END THERAPY AS REQUESTED. THE HP INDICATED HE FELT SO MUCH BETTER. THE TSR SUBSEQUENTLY SWAPPED THE CUSTOMER'S DEVICE. THE TSR DISCUSSED WITH THE HP USE OF MANUAL CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) EXCHANGES FOR PERITONEAL DIALYSIS UNTIL THE ARRIVAL OF THE REPLACEMENT DEVICE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR