BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1133245 · Received August 21, 2008

    Report

    Report Number
    1423500-2008-00759
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    May 31, 2008
    Report Date
    May 31, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOME CHOICE (HC) DEVICE DISPLAY DURING DWELL 1/2. THE HP STATED THE SUPPLY BAG HAD FALLEN OFF. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HP WAS GOING TO START THERAPY AGAIN WITH NEW CASSETTE AND BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THREE MONTHS LATER, DURING A FOLLOW UP CALL, THE HP'S NURSE STATED THAT THE HOME PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT THEN SWITCHED TO HEMODIALYSIS AND WAS SCHEDULED TO HAVE HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization