BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6999824 · Received November 3, 2017

    Report

    Report Number
    1722028-2017-00432
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 3, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TERUMO BCT (B)(4), INC WAS NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THE INFLATED SAMPLE BAG. TERUMO BCT (B)(4), INC PROVIDED PHOTOGRAPHS OF THE SET TO TBCT (B)(4) AND IT WAS CONFIRMED THAT THE SAMPLE BAG WAS INFLATED AND CONTAINED BLOOD. IT COULD NOT BE DETERMINED IF THE WHITE PINCH CLAMP WAS FULLY CLOSED ON THE TUBING. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF SHOWED A ¿PRESSURE TEST ERROR¿ ALERT WAS GENERATED DURING THE TUBING SET TEST WHILE THE SYSTEM WAS ATTEMPTING TO POSITIVELY PRESSURIZE THE TUBING SET. IT IS SUSPECTED THAT THIS ALERT WAS GENERATED BECAUSE THE PINCH CLAMP ON THE SAMPLE BAG LINE WAS LIKELY NOT OCCLUDING THE TUBING PROPERLY. IF THE CLAMP ON THE SAMPLE BAG LINE IS NOT OCCLUDING THE TUBING PROPERLY DURING THE TUBING SET TEST, AIR CAN HAVE A PATHWAY TO ENTER THE SAMPLE BAG. SIGNALS IN THE RDF ALSO SHOWED THAT AFTER THE OPERATOR CONTINUED FROM THE ¿PRESSURE TEST ERROR¿ ALERT, THE TUBING SET TEST PASSED. IT IS POSSIBLE THAT AFTER THE ¿PRESSURE TEST ERROR¿ ALERT, THE OPERATOR ADJUSTED THE CLAMP BUT DID NOT EXPRESS THE AIR FROM THE SAMPLE BAG AS THE SAMPLE BAG WAS INFLATED WITH A SMALL AMOUNT OF DONOR BLOOD UPON RETURN TO THE TERUMO BCT (B)(4), INC. ROOT CAUSE: REVIEW OF THE RUN DATA FILE SHOWED BASED ON THE AVAILABLE EVIDENCE, THE ROOT CAUSE FOR THE INFLATED SAMPLE BAG WAS NOT ABLE TO BE DETERMINED. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO:-THE USER DID NOT CLOSE THE CLAMP WHEN PROMPTED TO DO SO-THE USER CLOSED THE CLAMP BUT THE CLAMP WAS NOT FULLY OCCLUDING THE SAMPLE BAG LINE. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF AIR IN SAMPLE BAG.

    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. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    PATIENT (DONOR) GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLLECTION PROCEDURE, THEY FOUND THE SAMPLE BAG WAS FILLED WITH AIR. PER THE CUSTOMER, THE OPERATOR NOTED THAT THE WHITE PINCH CLAMP WAS CLOSED. THE CUSTOMER STATED THAT NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT AS NO AIR WENT TO THE DONOR, AND THE DONOR IS 'OK'. DUE TO (B)(6) PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO AN ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780197 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET JAPAN GKT TERUMO BCT 1706025251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other