BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 373950 · Received January 23, 2002

    Report

    Report Number
    1423500-2002-00077
    Event Type
    Other
    Date Received
    January 23, 2002
    Date of Event
    October 22, 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) REPORTS A PATIENT WITH 2 EPISODES OF PERITONITIS. THE FIRST INCIDENT OCCURRED IN 2001 AND THE PATIENT WAS NOTED TO HAVE CLOUDY EFFLUENT AND ABDOMINAL PAIN. PATIENT WAS TREATED WITH CEFAZOLIN 500MG INTRAPERITONEALLY (IP) LOADING DOSE AND CEFAZOLIN 125MG/L MAINTENANCE DOSE FOR 7 DAYS. A WEEK LATER, THE MEDICATION WAS CHANGED TO VANCOMYCIN 2 GM. LOADING DOSE AND VANCOMYCIN 1 GM IP WEEKLY FOR 2 WEEKS, MAINTENANCE DOSE. THE HCP VERBALIZED THAT THE REPORTED INCIDENT MAY BE ATTRIBUTED TO USER ERROR, AS PATIENT DOES NOT OBSERVE ASEPTIC TECHNIQUE WITH PROPER HANDWASHING. THE SECOND PERITONITIS INCIDENT OCCURRED 2 MONTHS LATER. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND WAS NOTED TO HAVE CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GM. LOADING DOSE AND VANCOMYCIN 1 GM IP WEEKLY FOR 2 WEEKS, MAINTENANCE DOSE. THE PATIENT HAS RECOVERED PER THE RN.

    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 40 YR Other HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT.