BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3083338 · Received April 29, 2013

    Report

    Report Number
    1722028-2013-01137
    Date Received
    April 29, 2013
    Date of Event
    March 26, 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

    INVESTIGATION: THE RETURNED SET WAS VISUALLY EXAMINED. THE TUBING WAS DETACHED AT THE PLASMA LINE TO TOP OF T-CASSETTE. THE LINE HAD SOLVENT AND A MARK INDICATING THAT IT WAS ONLY INSERTED BY 3MM (BOND SOCKET LENGTH IS APPROX 11MM).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 RESULTS OF THE INVESTIGATION COMPLETED ON THE RETURNED DISPOSABLE SET,SUGGEST THAT THE ROOT CAUSE IS RELATED TO A MANUFACTURING ISSUE. THIS CAN BE ATTRIBUTED, BUT NOT LIMITED TO:-TUBING NOT FULLY SEATED IN BOND PORT-EXCESS SOLVENT IN BOND PORT-CASSETTE MISHANDLED AFTER TUBING WAS INSERTED INTO BOND PORT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PLASMA TUBING WAS NOT CONNECTED PROPERLY TO THE CASSETTE, SO DURING COLLECTION, THE COLLECTED PLASMA CAME OUT OF THE SET. NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE FULL PATIENT IDENTIFIER IS (B)(6).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
    184858 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC AUTO PAS SET GKT TERUMO BCT 02V1214

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR