BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 373954 · Received January 23, 2002

    Report

    Report Number
    1423500-2002-00078
    Event Type
    Other
    Date Received
    January 23, 2002
    Date of Event
    November 29, 2001
    Report Date
    December 27, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) RPEORTS PATIENT WITH PERITONITIS EPISODE. PATIENT WAS NOTED TO HAVE EFFLUENT WHICH APPEARED BLOODY AND HAZY. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFAZOLIN 500MG/L, LOADING DOSE AND IP CEFAZOLIN 125MG/L, MAINTENANCE DOSE. IN 2001, THE MEDICATION WAS CHANGED TO IP VANCOMYCIN 2GM, LOADING DOSE. THE PATIENT HAS RECOVERED PER HCP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT.