BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 127701 · Received October 20, 1997

    Report

    Report Number
    1423500-1997-00022
    Event Type
    Injury
    Date Received
    October 20, 1997
    Date of Event
    September 24, 1997
    Report Date
    September 24, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 9/24/97, PT DEVELOPED PERITONITIS WHILE USING HOMECHOICE PD CYCLER. PT WAS TREATED AS AN OUTPATIENT WITH CEFIZOL 1GM IP X 10DAYS AND GENTAMYCIN 40MG IP X 10 DAYS. REPEAT CULTURE OF EFFLUENT ON 10/5/97 WAS NEGATIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other