BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL (PLT)

    MDR report key: 1890818 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00027
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    February 11, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE ACDA SOLUTIONS USED WERE FROM TWO DIFFERENT LOTS. THE TWO INCIDENTS THAT OCCURRED DURING A TRIMA ACCEL COLLECTION USED TRIMA DISPOSABLE KITS FROM THE SAME LOT NUMBER 12R1115. SYNCOPE EPISODES HAVE SIMILAR CHARACTERISTICS, BUT CAN BE CAUSED BY MANY DIFFERENT TYPES OF STIMULI. ROOT CAUSE: THESE DISPOSABLE SETS WERE UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE PHYSICIAN POINTED TO DEHYDRATION AS THE ROOT CAUSE OF BOTH INCIDENTS. RISK ANALYSIS: THE TWO INDIVIDUALS EXPERIENCED A TYPE OF REACTION THAT IS LISTED IN THE TRIMA ACCEL AUTOMATED BLOOD COLLECTION OPERATOR'S MANUAL (TRIMA, 2009). THE RATE OF OCCURRENCE OF ALL REPORTED PATIENT REACTIONS ON TRIMA DISPOSABLE KITS MANUFACTURED IN 2009 WAS LESS THAN 1 IN 100,000.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QUALITY ASSURANCE ON (B)(6) 2010. WITHIN A 2-3 WEEK PERIOD, TWO TRIMA DONORS EXPERIENCED LOSS OF CONSCIOUSNESS AND PROLONGED RECOVERY. BOTH INDIVIDUALS FULLY RECOVERED WITHOUT SIGNIFICANT MEDICAL INTERVENTION OR FOLLOW-UP TREATMENT. THE MEDICAL DIRECTOR DID NOT BELIEVE THAT THE INCIDENTS WERE RELATED AND DID NOT ALLEGE A DEFICIENCY OF THE TRIMA MACHINE OR DISPOSABLE KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL (PLT) SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 12R1115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention