BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 8608017 · Received May 13, 2019

    Report

    Report Number
    MW5086595
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    May 8, 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; 12 MINS INTO THE DEPLETION PHASE, THE PT EXPERIENCED A FEELING OF "WATER IN HIS EARS", CHEST TIGHTNESS, COUGH, PAIN, AND HYPOXEMIA WITH OXYGEN SATURATIONS IN THE MID-80S. HIS SYMPTOMS RESOLVED WITH 40MG IV PEPCID AND 4L OXYGEN VIA NASAL CANNULA. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399825 SPECTRA OPTIA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 190403330

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other