BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 381465 · Received March 4, 2002

    Report

    Report Number
    1423500-2002-00288
    Event Type
    Malfunction
    Date Received
    March 4, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 5, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REPORTED BEING OVERFILLED WITH FLUID WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HP REPORTEDLY HAD A DAY DWELL OF 2500MLS IN PERITONEUM, WHICH COULD TYPICALLY BE DRAINED OUT DURING THE INITIAL PHASE OF THE SUBSEQUENT APD THERAPY. HP REPORTEDLY ONLY DRAINED 10MLS OF THIS FLUID WHEN THE CYCLER ADVANCED FROM THE INITIAL DRAIN INTO FILL 1. THE HP REPORTED DURING FILL 1 HP RECEIVED 2135MLS OF THE TARGET FILL VOLUME OF 3000MLS WHEN HP FELT TIGHT AND FULL. THE HP PLACED AN ADDITIONAL BAG OF SOLUTION ONTO THE CYCLER SET TO MAKE UP FOR THE LOST FILL VOLUME AND CONTINUED APD THERAPY. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN