BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 4200514 · Received October 24, 2014

    Report

    Report Number
    1722028-2014-00428
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TWO TRIMA ACCEL SETS WERE RECEIVED FOR INVESTIGATION. EACH KIT WAS LEAK TESTED AND A LEAK WAS FOUND AT THE CONTROL Y CONNECTOR OF EACH SET. SPECIFICALLY, THE LEAK SOURCE WAS AT THE KNIT LINE OF THE RBC PORT OF THE CONTROL Y. THE CUSTOMER ALSO SENT PHOTOGRAPHIC EVIDENCE OF THE BLOOD SPRAY CONFIRMING THE SOURCE OF THE LEAK. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: THE LEAK IN THE CONTROL Y PARTS IS DUE TO A LEAK PATH AT THE KNIT LINE AND IS LOCATED ON THE FIRST SHOULDER OF THE CONTROL Y NEAR THE RBC PORT. THE KNIT LINE IS CREATED AS A NORMAL PART OF THE MOLDING PROCESS. IN THIS CASE, THE INJECTION PROCESS WAS SHUT OFF PREMATURELY AND THE MATERIAL DID NOT COMPLETELY FILL ALONG THE KNIT LINE AND A VOID OR GAP RESULTED. DURING CENTRIFUGATE THE CONTROL Y IS SUBJECT TO HIGH INTERNAL PRESSURE AND AN OPENING CAN FORM ALONG THE KNIT LINE WHICH CAN ALLOW FOR A LEAK PATH. THIS TYPE OF LEAK IS A VERY FINE SPRAY WHICH MAY NOT SIGNAL THE CENTRIFUGE'S LEAK DETECTOR TO ALARM. CORRECTIVE ACTION: THE ROOT CAUSE HAS BEEN IDENTIFIED AND AN IMMEDIATE CORRECTIVE ACTION HAS BEEN IMPLEMENTED AT THE SUPPLIER. THE CORRECTIVE ACTION IS TO INCREASE THE MAXIMUM TIME ALLOWED FOR FILLING OF THE MOLD TO ENSURE AN ADEQUATE RESIN INJECTION TIME. THIS ALLOWS FOR A COMPLETE KNIT LINE OF THE PART.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY EXPERIENCED A LEAK ON 2 DISPOSABLE SETS. THE BLOOD LEAK WAS FOUND INSIDE THE CENTRIFUGE. THEY DID NOT RECEIVE AN ALARM. NO MEDICAL INTERVENTION WAS NECESSARY. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678436 TRIMA ACCEL TRIMA ACCEL PLATELET, SAMPLER, AUTOPAS, MLTPLASMA SET GKT TERUMO BCT 07W1201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other