BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 6186233 · Received December 19, 2016

    Report

    Report Number
    1722028-2016-00653
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 8, 2016
    Report Date
    December 19, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K153601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. .INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. 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. RDF ANALYSIS DID NOT SHOW A CONCLUSIVE ROOT CAUSE FOR THE CONTAMINATIONS REPORTED FOR THIS COLLECTION. ANALYSIS SHOWED ALL SIGNALS APPEARED AS EXPECTED. BASED ON THE COMPLAINT DESCRIPTION AND PAST EXPERIENCE WITH MEASURING OPTIA PLATELET COLLECTION PRODUCTS, A POSSIBLE CAUSE FOR THE CONTAMINATIONS REPORTED INCLUDES, BUT IS NOT LIMITED TO, THE DIFFERING SAMPLE MEASUREMENT METHODS AND PRODUCT HANDLING. FOR EXAMPLE, IF USING FLOW CYTOMETRY, MEASUREMENTS SHOULD BE GATED FOR A PLATELET COLLECTION AND NOT AN MN COLLECTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, AN ADVEA TESTING DEVICE WAS USED TO MEASURE THE WBC CONTAMINATION WITH THE FLOW CYTOMETER. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. RDF ANALYSIS DID NOT SHOW A CONCLUSIVE ROOT CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) COUNT REPORTED FOR THIS COLLECTION. ANALYSIS SHOWED ALL SIGNALS APPEARED AS EXPECTED. BASED ON THE EVENT DESCRIPTION AND PAST EXPERIENCE WITH MEASURING OPTIA PLATELET COLLECTION PRODUCTS, IT IS POSSIBLE THAT THE SAMPLE MEASUREMENT METHODS MAY HAVE CONTRIBUTED TO THE ELEVATED WBC COUNT REPORTED. FOR EXAMPLE, IF USING FLOW CYTOMETRY, MEASUREMENTS SHOULD BE GATED FOR A PLATELET COLLECTION AND NOT ANMONONUCLEAR CELL COLLECTION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLASMA BAG POST COLLECTION OF A PLATELET RICH PLASMA (PRP) PRODUCT. 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 A 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
    835854 SPECTRA OPTIA SPECTRA OPTIA PLATELET PLASMA SET LKN TERUMO BCT 03Z3125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other