BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL BLOOD COLLECTION SET

    MDR report key: 1890523 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00030
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    February 15, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LJT
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PT DID NOT EXHIBIT ANY UNUSUAL SYMPTOMS AND THE OPERATOR DID NOT NOTICE EXCESSIVE VOLUME IN THE RED BLOOD CELL COLLECT BAG. THE CUSTOMER DID NOT EXPRESS CONCERN OVER THE TRIMA MACHINE'S PERFORMANCE. THE RBC COLLECTION WAS 17% IS OUTSIDE OF THE CARIDIANBCT +/-10% SPEC. NO ADVERSE HEALTH EFFECTS WERE EXPERIENCED BY THE DONOR. THE TOTAL COLLECT VOLUME INCLUDING OVERAGE DID NOT EXCEED 15% OF THE DONOR'S TOTAL BLOOD VOLUME. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. ACCORDING TO ANALYSIS OF THE RUN DATA FILE AND A CONVERSATION WITH THE CUSTOMER, INCORRECT ORIENTATION OF THE HEX IN THE HEX HOLDER MAY HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED RBC VOLUME MEASUREMENT. IT IS ALSO POSSIBLE THAT THE EMPTY BAG WEIGHT WAS NOT CONSIDERED IN THE VOLUME CALCULATION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QUALITY ASSURANCE. THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE HIGH-MEASURED RBC PRODUCT VOLUME. NO SAFETY ISSUE WAS ALLEGED TO HAVE OCCURRED OR TO BE LIKELY TO OCCUR. THE CUSTOMER CONTACTED CARIDIANBCT ON A LATER DATE TO PROVIDE THE MEASURED VOLUME OF RBCS COLLECTED. BECAUSE THE REPORTED MEASUREMENT WAS GREATER THAN 10% OF THE TARGET, THIS COMPLAINT IS BEING REPORTED UNDER MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL BLOOD COLLECTION SET SEPERATOR, AUTOMATED, BLOOD CELL AND PL LJT CARIDIANBCT 917000000 01S3105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other