BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3950455 · Received July 22, 2014

    Report

    Report Number
    1722028-2014-00279
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 25, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE PART EVALUATION DID NOT SHOW ANY ISSUES WITH THE DISPOSABLE SET. THE RDF INDICATES IT IS POSSIBLE THAT THE WHITE PINCH CLAMP TO THE SAMPLE BAG WAS ONLY PARTIALLY OCCLUDED. IT MAY ALSO BE POSSIBLE THAT THIS KIT WAS LOADED ON ANOTHER MACHINE THAT SAME DAY WHERE THE SAMPLE BAG WAS INFLATED THEN RELOADED ONTO THIS MACHINE CORRECTION: A VOLUNTARY MEDICAL DEVICE PRODUCT RECALL WAS RELEASED BY TERUMO BCT TO COMMUNICATE MORE INFORMATION ABOUT THE "AIR IN THE SAMPLE BAG SAFETY ALERT" TO THE CUSTOMER. ADDITIONALLY, THE CUSTOMER SITE RECEIVED TRAINING FROM TERUMO BCT REGARDING AIR IN SAMPLE BAG. CORRECTIVE/PREVENTIVE ACTION: IF SCREEN PROMPTS ARE NOT FOLLOWED CORRECTLY, THE POSSIBILITY OF RETUNING AIR TO THE DONOR EXISTS. AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS THE AIR IN SAMPLE BAG ISSUE.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION IT WAS NOTED THAT THE SAMPLE BAG WAS INFLATED WITH AIR. BLOOD WAS ALSO NOTED IN THE SAMPLE BAG AND ACCESS LINE ONLY. BOTH WHITE CLAMPS WERE CLOSED AND BLUE CLAMP WAS ALSO CLOSED. NO LEAKS FROM THE BAG WERE NOTED. NO MIS-ASSEMBLES OF THE SET WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. BASED ON THE RDF, IT MAY BE POSSIBLE THAT THE WHITE PINCH CLAMP TO THE SAMPLE BAG WAS ONLY PARTIALLY OCCLUDED. IT MAY ALSO BE POSSIBLE THAT THIS KIT WAS LOADED ON ANOTHER MACHINE THAT SAME DAY WHERE THE SAMPLE BAG WAS INFLATED THEN RELOADED ONTO THIS MACHINE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CLAMPS WERE NOT DEFECTIVE,HOWEVER THE OPERATOR MAY HAVE POSITIONED THEM TO ONLY PARTIALLY OCCLUDE THE SAMPLE BAG LINE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ALARM, 'PLEASE CHECK CLAMPS' WHILE LOADING THE DISPOSABLE SET. THE NURSE ADJUSTED THE CLAMPS AND CONTINUED WITH THE LOADING. AFTER THE VENIPUNCTURE OF THE DONOR, THE NURSE OPENED THE CLAMPS. THE NURSE NOTICED SOME BLOOD WENT INTO THE SAMPLE BAG AND AIR FILLED THE SAMPLE BAG. THE NURSE DISCONNECTED THE DONOR. NO INJURY WAS REPORTED WITH THIS INCIDENT. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY HAS OCCURRED.

    Description of Event or Problem · 1

    THE DONOR'S GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF) ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428283 TRIMA ACCEL TRIMA ACCEL PLT,PLT FILTER,AUTOPAS,PLS,RBC,TLR FILTER GKT TERUMO BCT 04W2124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other