BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL (PLT)

    MDR report key: 1972811 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00154
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    February 11, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    GKT
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PT REACTIONS ON TRIMA DISPOSABLE KITS MFG IN 2009 WAS LESS THAN 1 IN 100,000. CONCLUSION: THE DEVICE OPERATED AS INTENDED. HYPOCALCEMIC REACTIONS ARE A KNOWN SIDE EFFECT OF APHERESIS PROCEDURES.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. DONOR PALE, LIGHTHEADED, HOT AND DIAPHORETIC. LOC FOR 30-45 SEC WITH TETANY. AMMONIA INHALANT USED AND DONOR PLACED IN SUPINE POSITION FLUIDS GIVEN, HEAD LOWERED, KNEES ELEVATED, COUGH ENCOURAGED, COLD PACK APPLIED, AND INSTRUCTIONS GIVEN. PROLONGED RECOVERY NOTED, OVER 1 HR. DISCHARGED UNDER CARE OF WIFE. STAFF CALLED LATER IN THE DAY, DONOR FEELING GOOD. FOLLOW UP CALL NEXT DAY, DONOR FINE WITH NO COMPLAINTS. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention