BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1882185 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04925
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 12, 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 OVERPRIME WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER INFORMATION WAS NOT AVAILABLE. 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.

    Description of Event or Problem · 1

    A HOME PATIENT'S CAREGIVER REPORTED THAT WHILE PRIMING THE CASSETTE, THE SOLUTION STARTED POURING OUT. THE CAREGIVER SAID SHE CHECKED THE SUPPLIES AND THEY WERE ALL FINE AND EVERYTHING WAS CLAMPED LIKE IT SHOULD BE. ALL SUPPLIES WERE DISCARDED AND THE NEXT SET OF SUPPLIES WERE FINE. PRODUCT INFORMATION UNKNOWN. THE PATIENT HAS BEEN PERFORMING THERAPY FINE WITHOUT FURTHER COMPLICATIONS SINCE THIS INCIDENT.

    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 57 YR