BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3183040 · Received June 21, 2013

    Report

    Report Number
    1722028-2013-01258
    Date Received
    June 21, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 24, 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: PER THE CUSTOMER, THERE WAS PRESENCE OF TWO Y CONNECTIONS INSTEAD OF ONE ON THE PLATELET TUBING, BETWEEN THE PLATELETS COLLECTION BAG AND THE LEUKO REDUCTION FILTER. A LEAK WAS FOUND ON ONE OF THE Y CONNECTION WITH NO TUBING BONDED. THE DONOR SIGNALED THE LEAK WHEN SEEING BLOOD COMPONENT ON THE FLOOR. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE STILL 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, MANUFACTURING ABNORMALITY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A PHOTO SENT BY THE CUSTOMER SHOWED FLUID IN THE LINE JUST PAST WHERE THE EXTRA Y CONNECTOR IS. TWO SETS OF PLATELET BAGS WERE RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION AN EXTRA Y CONNECTION WAS NOTED ON THE LINE TO THE PRIMARY SET OF PLATELET BAGS. IT LEAKED AT THIS POINT. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE Y CONNECTION BETWEEN THE PLATELET COLLECTION BAG AND THE LEUKOREDUCTION FILTER DURING A PLATELET COLLECTION (PC) PROCEDURE. THE PRODUCT WAS COLLECTED FROM DONOR. NO MEDICAL INTERVENTION WAS NECESSARY FOR THE EVENT. THE PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. TERUMO BCT IS AWAITING THE RETURN OF THE DISPOSABLE SET. 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 CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER.

    Description of Event or Problem · 1

    THE DONOR IS UNDER SPECIAL MONITORING SINCE THE DONATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283685 TRIMA ACCEL TRIMA ACCEL PLT, PLT, FILTER AUTO PAS PLS RBC TLR FILT GKT TERUMO BCT 02V3215

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR