BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 174436 · Received June 22, 1998

    Report

    Report Number
    1423500-1998-01449
    Event Type
    Injury
    Date Received
    June 22, 1998
    Date of Event
    June 5, 1998
    Report Date
    June 17, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REPORTED PATIENT WITH EPISODE OF PERITONITIS DURING USE OF HOMECHOICE CYCLER. PATIENT WAS TREATED AS AN OUTPATIENT WITH ANCEF 2 GM. IP X 14 DAYS. AS OF DATE OF REPORT, PATIENT HAS RECOVERED. RN SUSPECTS PATIENT HAS BEEN SOMEWHAT CARELESS IN SET UP OF EQUIPMENT DURING TREATMENT AND HAS TOLD RN THAT HE DOES NOT ALWAYS WEAR A MASK AS INSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG HOMECHOICE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other