BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1770061 · Received July 25, 2010

    Report

    Report Number
    1423500-2010-01682
    Event Type
    Malfunction
    Date Received
    July 25, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 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). THIS REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED AS A SAMPLE OR BATCH DETAILS WERE NOT AVAILABLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, NOT ENOUGH DATA IS AVAILABLE WITHIN THE REPORT TO IDENTIFY ROOT CAUSE. A LABELING REVIEW WAS CONDUCTED AND THE LABELING WAS FOUND ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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 GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM AND SE 2367 ALARM ON THE HOMECHOICE UNIT DURING DWELL 2 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO RECYCLE THE POWER TO CLEAR THE ALARMS. THE HP STATED THE SPIKE MAY NOT HAVE BEEN FULLY PUSHED INTO THE SUPPLY BAG. THE TSR FURTHER EXPLAINED THE ALARMS AND ADVISED THE HP TO DISCARD SUPPLIES AND START OVER WITH NEW SUPPLIES. THE HP CONFIRMED TO CALL BACK WITH ANY FURTHER PROBLEMS OR QUESTIONS. 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 36 YR