BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING

    MDR report key: 13976602 · Received March 31, 2022

    Report

    Report Number
    MW5108685
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    March 25, 2022
    Report Date
    March 29, 2022
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLOOD LEAK AT BEGINNING OF PLASMAPHERESIS TREATMENT. THIS IS THE 3RD OCCURRENCE WITH THE SAME LOT NUMBER OF TUBING. THE LEAK WAS AT THE SAME LOCATION IN ALL 3 TUBING SETS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425065 TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 2203033130
    1425066 TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 2203033130
    1425067 TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 2203033130

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female