BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3073631 · Received April 23, 2013

    Report

    Report Number
    1722028-2013-01143
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. A CLEAN TRIMA DISPOSABLE SET WAS RECEIVED FOR INVESTIGATION. THE CHANNEL IS NOTICEABLY "PUFFY"PRESUMABLY DUE TO A CREASE PRESENT DURING WELDING, CAUSING EXCESS VINYL ON EXTERNAL SURFACE. THE EXCESS MATERIAL IS PRESENT FROM THE INLET PORT TO APPROX HALFWAY ALONG THE CHANNEL. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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: THE ROOT CAUSE FOR THIS EVENT IS MOST LIKELY A MANUFACTURING DEFECT DUE TO THE WELDING OPERATOR NOT ENSURING THAT THE CHANNEL VINYL WAS ADEQUATELY DOWN ON THE ALIGNMENT PINS DURING THE WELDING PROCESS. CORRECTION: INFORMATION REGARDING THIS FAILURE WAS COMMUNICATED TO TERUMO BCT RF ENGINEERING DEPARTMENT.

    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 DURING SET UP, THEY NOTICED THE CHANNEL OF THE CENTRIFUGE WAS TOOTHICK. WHEN INSERTING/SLIDING, IT DIDN'T SLIDE COMPLETELY INTO THE CENTRIFUGE. THE SET WAS NOT USED. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT INFORMATION. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175106 TRIMA ACCEL TRIMA ACCEL PLT, PLS, RBC AUTO PAS SET GKT TERUMO BCT 02V1214

    Patients

    Seq Age Sex Outcome Treatment
    1