BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II

    MDR report key: 334289 · Received May 19, 2001

    Report

    Report Number
    1811755-2001-00011
    Event Type
    Injury
    Date Received
    May 19, 2001
    Date of Event
    March 21, 2001
    Report Date
    April 28, 2001
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING CBC II, CONNECTOR PART SEEMED LOOSE AND APPEARED TO BE AIR LEAKAGE. AS THERE WAS NO SUBSTITUTE, PRODUCT WAS USED. PT GOT AN INFECTION AND IS NOW IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23678 CBC II APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS 0225-414-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention