BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2993210 · Received March 7, 2013

    Report

    Report Number
    1722028-2013-00988
    Date Received
    March 7, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. ROOT CAUSE: BASED ON THE CUSTOMER'S DESCRIPTION, THE ROOT CAUSE OF THIS INCIDENT IS THE PHLEBOTOMY OR THE ADJUSTMENT OF THE NEEDLE BY THE OPERATOR IN THE DONOR'S ARM IN AN ATTEMPT TO GET THROUGH THE DRAW FLOW ALERTS CAUSED THE TORN BICEP.

    Additional Manufacturer Narrative · 1

    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 ON (B)(6) 2013, 4 DAYS POST-DONATION , THE DONOR EXPERIENCED PAIN IN HER BICEPS AS A RESULT OF A PLATELET DONATION. SHE WENT TO THE ER AND WAS TREATED FOR A TORN BICEPS MUSCLE AND HAD A SEVERE HEMATOMA. THE CUSTOMER IS UNAWARE IF THE DONOR IS TAKING MEDICATION AS A RESULT OF HER INJURY. THE DONOR STATES SHE WILL NEED SURGICAL REPAIR OF HER TORN BICEPS. DURING THE DONATION, THE DONOR COMPLAINED OF A PAINFUL PHLEBOTOMY, AND CONTINUED TO VOICE HER DISCOMFORT TO THE OPERATOR THROUGH OUT THE RUN. PER THE CUSTOMER, THE OPERATOR ATTEMPTED TO ADJUST THE NEEDLE. PER THE DONOR, SHE CONTINUED TO EXPERIENCE PAIN FOR FOUR MORE DAYS THEN DECIDED TO GO TO THE ER. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION VIA ER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96907 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 11U1315

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other