BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3073547 · Received April 23, 2013

    Report

    Report Number
    1722028-2013-01140
    Date Received
    April 23, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    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. BACTERIAL CONTAMINATION CAN OCCUR AT ANY POINT ALONG THE PROCESS OF COLLECTING PRODUCTS. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO:-IMPROPER CLEANSING AND/OR DONOR PREP-NOT DIVERTING THE FIRST 10ML OF DONOR BLOOD-IMPROPER STORAGE-UNDETECTED MISASSEMBLY IN THE SET

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED STERILITY TESTING IN THE QUALITY CONTROL LABORATORY REVEALED POSITIVE CONTAMINATION. THE CUSTOMER WAS NOT WILLING TO PROVIDE THE PATIENT IDENTIFIER. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF MALFUNCTION WITH THE POTENTIAL FOR INJURY OCCURRED.

    Description of Event or Problem · 1

    THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT,THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN. PATIENT INFORMATION: NONE THE DONOR INFORMATION WAS PROVIDED ORIGINALLY IN ORDER TO ALIGN WITH THE COMPLAINT INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174651 TRIMA ACCEL TRIMA ACCEL PLT, PLS, RBC AUTO PAS SET GKT TERUMO CORPORATION/TERUMO BCT 11U1216

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR