BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO SPECTRA OPTIA

    MDR report key: 7334325 · Received March 12, 2018

    Report

    Report Number
    MW5075833
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 9, 2018
    Manufacturer
    TERUMO BCT INC.
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A FEVER POST CENTRAL LINE PLACEMENT, RED CELL PRIME AND APHERESIS COLLECTION FOR CAR T CELL THERAPY (KYMRIAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176129 TERUMO SPECTRA OPTIA OPTIA LKN TERUMO BCT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization