BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 5302748 · Received September 14, 2004

    Report

    Report Number
    1423500-2004-01004
    Event Type
    Malfunction
    Date Received
    September 14, 2004
    Date of Event
    August 20, 2004
    Report Date
    August 20, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE HP CONTINUES TO USE THE DEVICE FOR APD THERAPY. THE INITIAL DRAIN ALARM SETPOINT WAS INADVERTENTLY PROGRAMMED TOO LOW, WHICH MAY HAVE RESULTED INA AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. AS A RESULT OF THIS INCIDENT, THE HP'S INITIAL DRAIN ALARM SETPOINT WAS INCREASED FROM 2000MLS TO 2500ML. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REPORTED FEELING FULL, AS IF SHE WERE OVERFILLED, WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HP HAD PERFORMED A MANUAL CAPD EXCHANGE OF 2500MLS DURING THE DAY, WHICH SHE EXPECTED TO DRAIN OUT DURING THE SUBSEQUENT INITIAL DRAIN PHASE OF APD THERAPY IN THE EVENING. THE HP STATED HER APD THERAPY AND PERFORMED HER INITIAL DRAIN, AFTER WHICH SHE RECEIVED HER PROGRAMMED FILL VOLUME OF 2500MLS. THE HP FELT OVERFILLED AND PLACED THE CYCLER INTO A MANUAL DRAIN, REMOVING 2953MLS OF FLUID. AFTERWARDS, THE HP CONTINUED APD THERAPY TO COMPLETION WITH NO FURTHER DIFFICULTIES AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. REVIEW OF THE DEVICE'S PROGRAM PARAMETERS REVEALED THE INITIAL DRAIN ALARM SETPOINT HAD BEEN INADVERTENTLY SET AT 2000MLS IN (B)(6) ; HOWEVER, IT SHOULD HAVE BEEN SET AT 2500MLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED) HOMECHOICE FKX BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR