BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 474910 · Received July 29, 2003

    Report

    Report Number
    1423500-2003-00789
    Event Type
    Injury
    Date Received
    July 29, 2003
    Date of Event
    May 8, 2003
    Report Date
    June 30, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM A HOME PT'S (HP) NURSE (RN) STATED THE HP HAD BEEN DIAGNOSED WITH PERITONITIS IS 2003. REPORTEDLY, HP EXPERIENCED CONSTIPATION AND CRAMPS IN 05/2003, BUT WAITED UNTIL THE CLINIC VISIT IN 2003 TO REPORT THESE SYMPTOMS TO THE RN. THE RN REPORTED THE HP'S EFFLUENT WAS CLOUDY. THE HP WAS GIVEN A LOADING DOSE OF FLUCYTOSINE, 1000 MG ORAL (PO), AND WAS INSTRUCTED TO TAKE FLUCYTOSINE 500 MG PO EVERYDAY FOR 6 WEEKS. IN ADDITION, THE HP WAS INSTRUCTED TO TAKE FLUCONAZOLE, 200 MG PO EVERYDAY FOR 6 WEEKS. IN 05/2003, HP WAS HOSPITALIZED IN CONNECTION WITH A PERITONITIS EPISODE. DURING THE HOSPITALIZATION, HP'S CATHETER WAS REMOVED AND HP WAS TRANSFERRED TO HEMODIALYSIS. LIMITED INFO WAS AVAILABLE REGARDING THE HP'S TREATMENT WHILE IN THE HOSPITAL, AND THE HP WAS RELEASED FROM THE HOSPITAL IN 06/2003. BASED ON THE ABSENCE OF PERITONITIS SYMPTOMS, THE RN REPORTED THE HP IS FULLY RECOVERED; HOWEVER, A FOLLOW UP CULTURE OF THE HP'S EFFLUENT WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R