BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

    MDR report key: 2625933 · Received June 15, 2012

    Report

    Report Number
    1722028-2012-00365
    Event Type
    Other
    Date Received
    June 15, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 22, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD 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. THERE WAS NOTHING IN THE RDF TO SHOW THE REASON FOR THE DONOR REACTION. THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. PER THE TRIMA ACCEL OPERATOR'S MANUAL "THE TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM HAS MANY SAFETY FEATURES. HOWEVER, A DONOR REACTION CAN OCCUR RAPIDLY. THEREFORE, IT IS IMPERATIVE THAT THE TRIMA ACCEL COLLECTION SYSTEM AND THE DONOR BE MONITORED THROUGHOUT THE PROCEDURE."

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF INDICATE THAT THE TRIMA ACCEL OPERATED AS INTENDED. 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 THE DONOR FELT LIGHT HEADED AND EXPERIENCED TINGLING DURING A DOUBLE PLATELET PROCEDURE. TWO DAYS AFTER THE PROCEDURE, THE DONOR FAINTED AND WAS HOSPITALIZED FOR TWO DAYS. THE CUSTOMER IS REQUESTING A RUN SUMMARY OF THIS PROCEDURE TO RULE OUT ANY CONTRIBUTING FACTORS. THE DISPOSABLE SET WILL NOT BE RETURNED BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL ENHANCED PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN TERUMO BCT 02U1214

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization