BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 8608260 · Received May 13, 2019

    Report

    Report Number
    MW5086607
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 9, 2019
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IS A SICKLE-CELL DISEASE PT UNDERGOING DEPLETION RED BLOOD CELL EXCHANGE; 14 MINS INTO THE DEPLETION PHASE, THE PT EXPERIENCED CHEST TIGHTNESS AND / OR CHEST PAIN AND COUGH. HIS SYMPTOMS RESOLVED WITH SUPPLEMENTAL OXYGEN AND EPINEPHRINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399782 SPECTRA OPTIA EXCHANGE SET SPECTRA OPTIA LKN TERUMO BCT, INC. 1903133230

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other