BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APO SET W/CASSETTE3-PRONG

    MDR report key: 1040694 · Received May 8, 2008

    Report

    Report Number
    1423500-2008-00327
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THAT A HOME PATIENT (HP) HAD A CASSETTE BURST WHILE PRIMING WITH THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) HAD RECEIVED AN ALARM ON THE MACHINE AND ATTEMPTED TO ADJUST THE BAGS TO CLEAR THE ALARM. THE ALARM DID NOT CLEAR AND THE HP SPIKED AN ADDITIONAL BAG ONTO THE SETUP IN AN ATTEMPT TO CONTINUE WITH PRIME. WHEN PRIMING WAS RESTARTED, THE CASSETTE BURST AND FLUID BEGAN SPRAYING OUT OF THE DOOR OF THE MACHINE. THE PT STOPPED THERAPY AS SOON AS POSSIBLE. THIS INCIDENT OCCURRED DURING PRIME AND THERE WAS NO PT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APO SET W/CASSETTE3-PRONG 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1