BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT (REFURBHISHED)

    MDR report key: 522871 · Received April 27, 2004

    Report

    Report Number
    1423500-2004-00409
    Event Type
    Injury
    Date Received
    April 27, 2004
    Date of Event
    March 30, 2004
    Report Date
    March 30, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOME PT (HP) REPORTED PAIN DURING DRAIN WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. THE HP HAS PAIN DURING THE INITIAL DRAIN AND THE LAST DRAIN. HP PERFORMS TIDAL THERAPY, WHICH ALLOWS A PT TO DRAIN TO A PROGRAMMED VOLUME THROUGHOUT THERAPY AND DRAIN TO EMPTY DURING THE INITIAL DRAIN AND LAST DRAIN. THE HP (LAST FILL VOLUME IS 500ML AND HP ABSORBS ALL BUT 200-250ML OF THIS FLUID EACH DAY). HP RELATED THAT HP'S INITIAL DRAIN ALARM SETPOINT IS 500ML AND HP FEELS THAT THIS IS TOO HIGH AND MAY BE EXACERBATING HP ALTHOUGH HP IS EMPTY OF FLUID. ACCORDING TO THE HP, THERE HAS BEEN NO RESULTING PAIN, INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other MINICAP DISCONNECT CAP, 2004,| DIANEAL SOLUTION (STRENGTH UNK) 2004,| HOMECHOICE APD SET WITH CASSETTE 4-PRONG, 2004.| FLEXICAP DISCONNECT CAP, 2004,