BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA WBC SET

    MDR report key: 2132474 · Received June 13, 2011

    Report

    Report Number
    1722028-2011-00172
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE TOP OF THE INLET AIR DETECTOR DURING A RUN. CARIDIANBCT IS AWAITING THE RETURN OF THE DISPOSABLE SET FOR EVAL. PHOTOS AND VIDEO HAVE BEEN SUBMITTED. PT IDENTIFIER INFO IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO THE BLOOD EXPOSURE OBSERVED IN THE SUBMITTED VIDEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WBC SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 01T15294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other