BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1243213 · Received November 10, 2008

    Report

    Report Number
    1423500-2008-00906
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). CUSTOMER SAMPLE RECEIVED; HOWEVER, EVALUATION NOT YET COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED DRAINING 4046MLS DURING THE INITIAL DRAIN USING THE HOMECHOICE SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HOME PATIENT (HP) FELT OVERFULL BEFORE AND DURING THE INITIAL DRAIN. THE HP DRAINED 4046MLS OF FLUID, WHICH REVEALED THE HP'S SYMPTOMS. REVIEW OF THE CYCLER'S PROGRAMMING REVEALED THE FOLLOWING: THERAPY=HI DOSE CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD), TOTAL VOLUME=12000ML, # OF DAY FILLS=1, DAY FILL VOLUME=2000ML, NIGHT THERAPY TIME=9:00, NIGHT FILL VOLUME=2500ML, LAST FILL VOLUME=2000ML, DEXTROSE=SAME NIGHT CYCLES=3, NIGHT DWELL TIME -2:20, INITIAL DRAIN ALARM=1500ML, COMFORT CONTROL=36, LAST MANUAL DRAIN = NO. THE TSR SUBSEQUENTLY SWAPPED THE CUSTOMER'S DEVICE. THE CALLER INDICATED THE CYCLER WOULD CONTINUE TO BE USED FOR THERAPY UNTIL THE ARRIVAL OF THE REPLACEMENT 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 75 YR