BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1884398 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04994
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL 3/5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. THE ROOT CAUSE OF THE REPORTED PROBLEM OF IS CURRENTLY BEING INVESTIGATED THROUGH CAPA NUMBER (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 ALARM (INDICATING AIR) ON THE HOMECHOICE MACHINE DURING DWELL 3/5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS AND THE HOMEPATIENT (HP) STATED SHE HAD LEFT A SPARE LINE CLAMP OPEN CAUSING 2240 IN DWELL 3/5. THE TSR EXPLAINED TO DISCARD ALL SUPPLIES AND TO REPORT ALARMS TO THE NURSE THE FOLLOWING NEXT MORNING. THE HP WOULD FINISH THAT NIGHT'S THERAPY MANUALLY. FOLLOW UP WITH THE NURSE REVEALED THAT THE PATIENT DID CALL HER REGARDING THE ALARM, AND NO MEDICAL INTERVENTION WAS NEEDED. THE NURSE FURTHER STATED THAT THE PATIENT IS DOING WELL ON THERAPY.

    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 23 YR