BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3033473 · Received April 3, 2013

    Report

    Report Number
    1722028-2013-01071
    Date Received
    April 3, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 4, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER'S QA WILL PERFORM ARM SCRUB QC CULTURE AS PART OF AN (B)(4). THE RUN DATA FILE (RDF) WAS ANALYZED FOR THE BACTERIAL CONTAMINATION EVENT. SIGNALS IN THE RDF INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THERE IS NO CLEAR CAUSE FOR THE BACTERIAL CONTAMINATION THAT WAS MEASURED IN THE PLATELET PRODUCT 5 DAYS AFTER COLLECTION. A PREVENTIVE MAINTENANCE (PM) CHECK WAS PERFORMED ON THE MACHINE FOLLOWING THE INCIDENT. THERE WERE NO ISSUES FOUND DURING THE PM. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE 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 WOULD HAVE CONTRIBUTED TO THE PATIENT DEATH AS EXPERIENCED BY THE CUSTOMER. QUALITY LABS AND STERILIZATION REQUIREMENTS ALL PASSED. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. THE CUSTOMER STATED THAT THEY ARE NOT ABLE TO PROVIDE AUTOPSY RESULTS FOR THE TRANSFUSED PATIENT. THE CUSTOMER STATED THAT THE DEATH OF THE PATIENT WAS NOT DUE TO THE TRANSFUSION. THE PATIENT HAD OTHER ILLNESS AND COMPLICATIONS, THE BLOOD TRANSFUSION WAS NEVER IMPLICATED. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THERE IS NO CLEAR CAUSE FOR THE BACTERIAL CONTAMINATION THAT WAS MEASURED IN THE PLATELET PRODUCT 5 DAYS AFTER COLLECTION. THE ROOT CAUSE IS POSSIBLY DUE TO INADEQUATE VENIPUNCTURE TECHNIQUE BY THE OPERATOR.

    Description of Event or Problem · 1

    ORIGINALLY THE CUSTOMER CALLED BECAUSE THEY HAD A COLLECTED PLATELET PRODUCT THAT TESTED POSITIVE FOR PROPIONIBACTERIUM ACNES ON DAY 5 OF THE POST-COLLECTION TESTING. THE PLATELET PRODUCT HAD BEEN TRANSFUSED TO A PATIENT ON DAY 2. THEY HAD ALSO COLLECTED A PLASMA PRODUCT THAT WILL BE DESTROYED. THE CUSTOMER SUSPECTS THE ARM SCRUB AS THE CAUSE FOR THE CONTAMINATION. UPON FOLLOW-UP, IT WAS DETERMINED THAT THE PATIENT WHO HAD RECEIVED THE PLATELET PRODUCT HAD EXPIRED 3 DAYS POST-TRANSFUSION. THE PATIENT EXPIRED DUE TO A MASSIVE INTRACRANIAL HEMORRHAGE. THE PLATELET IS NOT IMPLICATED IN THE DEATH OF RECIPIENT, NOR IS THE TRIMA MACHINE. THE IDENTIFIER AND WEIGHT OF THE PATIENT WHO EXPIRED ARE NOT AVAILABLE AT THIS TIME. THE DONOR UNIT IDENTIFICATION NUMBER IS (B)(6).THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO A PATIENT DEATH, ALTHOUGH NOT RELATED TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER WAS NOT ABLE TO PROVIDE THE PATIENT'S IDENTIFIER OR WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135700 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 01V1105

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR