BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2993354 · Received March 7, 2013

    Report

    Report Number
    1722028-2013-00989
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: 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. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND ANY CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED RBC PRODUCT VOLUME REPORTED FOR THIS COLLECTION. POSSIBLE ROOT CAUSES WERE PROVIDED IN THE INITIAL REPORT FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND ANY CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED RBC PRODUCT VOLUME REPORTED FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND TRIMA ACCEL OPERATED AS INTENDED. IT IS POSSIBLE THAT THE VOLUME DISCREPANCY WAS CAUSED BY A WEIGHING, CALCULATION, OR OTHER PROCESS ERROR. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A HIGHER THAN EXPECTED RED BLOOD CELL (RBC) PRODUCT VOLUME COLLECTED. THE COLLECTED RBC VOLUME WAS >15% OF THE DONOR'S TOTAL BLOOD VOLUME(TBV). THE TOTAL ESTIMATED VOLUME TAKEN FROM THE DONOR IS 991 ML. FIFTEEN PERCENT OF THE DONOR'S TBV IS 966 ML. THERE WAS NO MEDICAL INTERVENTION NECESSARY. THE ENTIRE PATIENT ID IS (B)(6). THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96719 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 12U1120

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR