BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 16242695 · Received January 25, 2023

    Report

    Report Number
    1722028-2023-00031
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 25, 2023
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.6, D.4, H.6 AND H.10. INVESTIGATION: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS LOT. THERE WERE NO EVENTS NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THE ELEVATED WBC COUNT EXPERIENCED BY THE CUSTOMER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO: RBC SPILL OVER CENTRIFUGE STOPPED RBC DETECTOR CALIBRATION ERROR POSSIBLE AIR BLOCK THE ORIENTATION OF THE TUBING AS LOADED IN THE CENTRIFUGE HEX HOLDER AND THE COMPROMISED STRUCTURAL INTEGRITY OF THE PLASMA TUBING. EFFECTIVELY, THERE IS A CERTAIN ORIENTATION IN THE HEX HOLDER THAT ALLOWS FOR THE RBC LINE TO LIE ON TOP OF THE PLASMA LINE AND, UNDER CERTAIN FLOW CONDITIONS, MAY CAUSE THE PLASMA LINE TO PINCH OFF. THIS IN TURN CAUSES HIGHER FLOW THROUGH THE LRS CHAMBER, WHICH MAY LEAD TO ELEVATED LEVELS OF WBCS IN THE PLATELET PRODUCT.

    Additional Manufacturer Narrative · 0

    LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(6) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY 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.

    Description of Event or Problem · 0

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: 220269 THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY 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
    568180 SPECTRA OPTIA SPECTRA OPTIA PLATELET PLASMA SET GKT TERUMO BCT 2112013230

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other