BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1770053 · Received July 25, 2010

    Report

    Report Number
    1423500-2010-01680
    Event Type
    Malfunction
    Date Received
    July 25, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 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 UNIT DURING DWELL 2 OF 4. THE HOME PATIENT (HP) STATED SHE 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 TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP AND ADVISED THE HP TO CYCLE POWER. THE HP STATED SHE WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THE TSR ALSO ADVISED THE HP TO NOTIFY THE NURSE OF THE ALARM. ON (B)(6) 2010, BAXTER PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP'S NURSE. THE NURSE STATED THE HP WAS DOING FINE AND REPORTED NO PROBLEMS REGARDING THIS INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR