BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2840644 · Received November 20, 2012

    Report

    Report Number
    1722028-2012-00883
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 25, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. ALSO, TO PROVIDE CORRECTED PATIENT WEIGHT. 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 DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. IF AIR ENTERS THE DISPOSABLE SET DURING THE AIR EVACUATION SEQUENCE DURING AIR REMOVAL, DUE TO A LEAK IN THE DISPOSABLE SET, IT IS POSSIBLE A SMALL VOLUME OF AIR WILL REMAIN IN THE DISPOSABLE SET. CORRECTIVE/PREVENTIVE ACTION: IT IS SUGGESTED THAT THE OPERATOR CLOSELY FOLLOWS THE DIRECTIONS ON THE SCREEN AND ENSURE THAT THERE IS NO AIR IN THE DISPOSABLE SET AND NO LEAKS EXIST PRIOR TO VENIPUNCTURE

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AIR IN THE DONOR LINE AT THE START OF THE DRAW CYCLE PORTION OF THE COLLECTION PROCEDURE. THE CUSTOMER ALLEGED THAT AIR WAS DRAWN IN THROUGH A PIN HOLE LEAK. NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT. THE FULL PATIENT ID IS (B)(6). THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, TUBING SET GKT TERUMO BCT 08U9112

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR