BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 477503 · Received August 7, 2003

    Report

    Report Number
    1423500-2003-00839
    Event Type
    Injury
    Date Received
    August 7, 2003
    Date of Event
    April 24, 2003
    Report Date
    July 16, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS HOME PT'S (HP) NURSE (RN) REPORTED THAT THE HP WAS HOSPITALIZED WITH PERITONITIS FOR FOUR DAYS IN 4/03. REPORTEDLY, THE HP PRESENTED AT THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND CLOUDY EFFLUENT. TREATMENT DURING HOSPITALIZATION IS UNK. HOWEVER, IS 04/2003 THE HP BEGAN A COURSE OF VANCOMYCIN 2G INTRAPERITONEAL EVERY 4 DAYS FOR 17 DAYS. BASED ON THE ABSENCE OF PERITONITIS SYMPTOMS EXPERIENCED BY THE PT IT WAS CONCLUDED THAT THE PT HAD FULLY RECOVERED. AS A RESULT, NO FOLLOW-UP CULTURE OR CELL COUNT WAS PERFORMED.

    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 32 YR Hospitalization| R