BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL

    MDR report key: 3300260 · Received August 21, 2013

    Report

    Report Number
    1722028-2013-01357
    Event Type
    Other
    Date Received
    August 21, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 25, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A TRIMA ACCEL SET WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION THE RESERVOIR WAS NOTED TO BE FULL. BLOOD HAD TRAVELED UP THE LINE INTO THE VENT BAG. NO MIS-ASSEMBLES OR DEFECTS OF THE SET WERE FOUND. 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A SERVICE CALL WAS PLACED AND THE TECHNICIAN CONFIRMED THAT THE MACHINE WAS OUT OF CALIBRATION. THE SERVICE TECHNICIAN RE-CALIBRATED THE MACHINE AT THE TIME OF THE SERVICE CALLA SUBSEQUENT SERVICE CALL CONFIRMED THE FUNCTIONALITY OF THE UPPER AND LOWER LEVEL SENSORS. ROOT CAUSE: THE ROOT CAUSE FOR THIS PARTICULAR ISSUE IS UNKNOWN AT THIS TIME. NO DISPOSABLE EFFECTS WERE IDENTIFIED. POSSIBLE CAUSES FOR LEVEL SENSOR ALARMS INCLUDE BUT ARE NOT LIMITED TO:- PARTIAL OBSTRUCTION TO THE ACCESS LINE- AIR BLOCK AT PLASMA LINE- DEFECTIVE INLET PUMP OR INLET PUMP OCCLUSION- FLUID TRAPPED IN UPPER PORTION OF LEVEL SENSOR RESERVOIR (FOAM IN RESERVOIR).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE FIRST RETURN CYCLE OF A PROCEDURE, THEY RECEIVED A "DETACH THE DONOR, SWITCH OFF THE MACHINE, AND CALL THE TECHNICIAN' ALARM. THE CUSTOMER STOPPED THE PROCEDURE AND PRODUCT WAS LOST. THE PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Description of Event or Problem · 1

    THE PATIENT'S FULL ID # IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405098 TRIMA ACCEL TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLASMA,RBC TLR FILT GKT TERUMO BCT 04V3106

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR