BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1770063 · Received July 25, 2010

    Report

    Report Number
    1423500-2010-01684
    Event Type
    Malfunction
    Date Received
    July 25, 2010
    Date of Event
    May 9, 2010
    Report Date
    May 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DRAIN 2. THE HOME PATIENT (HP) STATED HE WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED ANY TIME PRIOR TO THE ALARM. THE HP STATED ALL BAGS WERE PROPERLY SPIKED AND CONNECTED AND THERE WERE NO PATIENT EXTENSION LINES IN USE. THE HP CONFIRMED THERE WERE NO OPEN CLAMPS ON UNUSED SUPPLY LINES AND THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP IN ENDING THERAPY. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR