BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 373907 · Received January 23, 2002

    Report

    Report Number
    1423500-2002-00076
    Event Type
    Other
    Date Received
    January 23, 2002
    Date of Event
    November 30, 2001
    Report Date
    December 27, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP.
    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 PATIENT WITH PERITONITIS EPISODE. PATIENT NOTED TO HAVE CLOUDY EFFLUENT AND ABDOMINAL PAIN. PATIENT WAS HOSPITALIZED AT TIME OF REPORTED PERITONITIS FOR POST SURGICAL HIP INFECTION. HCP REPORTS PATIENT HAS HAD THEIR PERITONEAL DIALYSIS CATHETER REMOVED DUE TO A FUNGAL INFECTION. THE PATIENT WAS TREATED WITH ORAL ANTIFUNGAL MEDICATION (MEDICATION AND DOSAGE UNKNOWN). HCP VERBALIZED THAT REPORTED INCIDENT MAY BE ATTRIBUTED TO USER ERROR, AS PATIENT DID NOT PERFORM PERITONEAL DIALYSIS PER PROCEDURE. RN REPORTS PATIENT REMAINED HOSPITALIZED AND WAS TRANSFERRED TO HEMODIALYSIS. ADDITIONAL FOLLOW UP WITH HCP INDICATED PATIENT LATER EXPIRED IN THE HOSPITAL. (DATE UNKNOWN).

    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 CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H| O HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT.