BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2831567 · Received November 14, 2012

    Report

    Report Number
    1722028-2012-00872
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: OPERATOR ERROR. BASED ON THE EVALUATION OF THE RDF, THE DONOR NEEDLE LINE WAS MISTAKENLY CLAMPED DURING THE AIR EVACUATION PROCESS AND THE AIR WAS NOT EXPRESSED FROM THE SAMPLE BAG PRIOR TO DONOR CONNECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. ANALYSIS OF THE RDF SHOWS THAT THE 'PRESSURE DETECTED DURING BAG EVACUATION' ALERT WAS GENERATED DURING THE AIR EVACUATION PROCESS. THIS ALERT IS GENERATED IF THE DONOR NEEDLE LINE IS MISTAKENLY CLAMPED DURING BAG EVACUATION INSTEAD OF THE SAMPLE BAG LINE AS INSTRUCTED. IF THE SAMPLE BAG LINE WAS LEFT OPEN, AIR WOULD HAVE FILLED THE BAG UNTIL THE ALERT WAS GENERATED. IF THE OPERATOR DID NOT FOLLOW THE ON-LINE INSTRUCTIONS TO REMOVE THE AIR FROM THE BAG AT THIS TIME, THEN AIR WOULD HAVE REMAINED IN THE BAG. IT IS ASSUMED THAT THE OPERATOR SAW THE AIR IN THE SAMPLE BAG WHEN ATTEMPTING TO CONNECT THE DONOR AND ENDED THE RUN. THE ANALYSIS SHOWED THAT THE DONOR WAS NOT CONNECTED AND THAT THE OPERATOR ACTED CORRECTLY IN ENDING THE PROCEDURE PRIOR TO DONOR CONNECTION. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLLECTION PROCEDURE, AFTER VENEPUNCTURE, UPON OPENING THE CLAMP TO THE SAMPLE BAG, THEY NOTICED AIR IN THE BAG. PATIENT ID AND WEIGHT ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Description of Event or Problem · 1

    NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, TUBING SET, UK GKT TERUMO BCT 07U9106

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other