BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBISHED)

    MDR report key: 511491 · Received February 12, 2004

    Report

    Report Number
    1423500-2004-00129
    Event Type
    Injury
    Date Received
    February 12, 2004
    Date of Event
    January 12, 2004
    Report Date
    January 12, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE HOME PT (HP) REPORTED FEELING ABDOMINAL PAIN, AS IF THEY WERE OVERFILLED, WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HP REPORTED THEY HAD APPROXIMATELY 2000ML IN THEIR PERITONEUM AT THE TIME THAT THEY STARTED APD THERAPY. THE HP REPORTEDLY DRAINED -10ML WHEN THE HOMECHOICE DEVICE ADVANCED FROM THE INITIAL DRAIN INTO FILL 1. THE HP THEN FILLED WITH 2552ML OF FLUID AND FELT OVERFILLED. THE HP PERFORMED A MANUAL DRAIN AND REMOVED 2002ML OF FLUID, AFTER WHICH THEY CONTINUED WITH THEIR APD THERAPY. REVIEW OF THE HP'S PROGRAM PARAMETERS REVEALED THAT ALTHOUGH THEY STARTED THE APD THERAPY WITH FLUID IN THEIR PERITONEUM, THE INITIAL DRAIN ALARM SETPOINT WAS PROGRAMMED AT 0ML. THERE WAS NO RESULTING 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 CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other 3-PRONG, 2004.| HOMECHOICE INTEGRATED APD SET WITH CASSETTE| DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2004.| MINICAP DISCONNECT CAP, 2004.