BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCONCENTRATOR PACK

    MDR report key: 260801 · Received January 28, 2000

    Report

    Report Number
    1718850-2000-00003
    Event Type
    Other
    Date Received
    January 28, 2000
    Report Date
    December 28, 1999
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE GLYCERIN IN THE HEMOCONCENTRATOR WAS ACCIDENTALLY INFUSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCONCENTRATOR PACK CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other