BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2840606 · Received November 20, 2012

    Report

    Report Number
    1722028-2012-00882
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RUN DATA FILE DO NOT INDICATE A CONCLUSIVE CAUSE FOR THE REPORTED DONOR REACTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THE TOTAL VOLUMES COLLECTED WERE WITHIN THE SAFETY LIMIT OF 15% OF THE DONOR'S TOTAL BLOOD VOLUME. BASED ON THE RDF ANALYSIS, THE TRIMA ACCEL SYSTEM FUNCTIONED AS INTENDED. VASOVAGAL REACTION IS A KNOWN POSSIBLE SIDE EFFECT FOR APHERESIS PROCEDURES. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THE DONOR REACTION REMAINS UNDETERMINED AT THIS TIME. POSSIBLE ROOT CAUSES WERE PROVIDED IN THE INITIAL REPORT FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DONOR HAD A MILD VASOVAGAL REACTION DURING A COLLECTION PROCEDURE. MEDICATION (ETILEFRIN) WAS GIVEN TO THE DONOR. PATIENT AGE IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION VIA ETILEFRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC SET GKT TERUMO BCT 06U3123

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R