BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 371151 · Received January 8, 2002

    Report

    Report Number
    1423500-2002-00017
    Event Type
    Other
    Date Received
    January 8, 2002
    Date of Event
    December 12, 2001
    Report Date
    December 12, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) FOR ASSISTANCE IN DRAIN 1/5 OF THE HP'S AUTOMATED PERITONEAL DIALYSIS (APD) TREATMENT WITH THE HP'S HOMECHOICE MACHINE. REPORTEDLY, HP WENT TO THE EMERGENCY ROOM EARLIER THAT EVENING COMPLAINING OF ABDOMINAL PAIN AND WAS DIAGNOSED WITH PERITONITS. HP WAS THEN ADMINISTERED 2 GRAMS OF VANCOMYCIN INTRAPERITONEAL. LATER THAT SAME EVENING A CULUTURE WAS TAKEN WHICH REVEALED STAPH ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX WITH A CELL COUNT OF 1,230. AFTER THIS DISCOVERY, RN CHANGED HP'S OUT PATIENT TREATMENT TO 40 MILLIGRAMS OF GENTAMICIN INTRAPERITONEAL FOR 14 DAYS. PER RN, HP HAS RECOVERED FROM THE INFECTION AND DENIES ANY BREAK IN ASEPTIC TECHNIQUE.

    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 72 YR Other