BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 6820251 · Received August 25, 2017

    Report

    Report Number
    9681839-2017-00097
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 31, 2017
    Report Date
    August 25, 2017
    Manufacturer
    TERUMO CORPORATION
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER, EXPIRY AND MANUFACTURE DATE NOT AVAILABLE AT THIS TIME.STN # BN 880217TERUMO BCT, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF FUJINOMIYA FACTORY OF TERUMOCORP., (MANUFACTURER). EXEMPTION NUMBER: E2015056.INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD A UNIT OF PLASMA DERIVED FROM WHOLE BLOOD WITH A REDTINGE THEY BELIEVE IS DUE TO HEMOLYSIS.THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF WHOLE BLOOD PROCESSING,THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.THE WHOLE BLOOD COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THECUSTOMER.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE EVENT REPORTED BY THE CUSTOMER HAS DETERMINED THAT DUPLICATE INFORMATION WAS PROVIDED TO TERUMO BCT. THE INFORMATION PROVIDED IN THE INITIAL REPORT FOR THIS EVENT HAS BEEN DETERMINED TO BE INFORMATION THAT WAS ALSO REPORTED IN MDR # 9681839-2017-00094. NO EVENT OCCURRED FOR THIS REPORT, THEREFORE, THERE IS NO FURTHER INFORMATION TO PROVIDE. PLEASE SEE 9681839-2017-00094 FOR INVESTIGATION OF THAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599865 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other