BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA WHITE BLOOD CELL SET, CLOSED

    MDR report key: 2211356 · Received August 3, 2011

    Report

    Report Number
    1722028-2011-00284
    Event Type
    Other
    Date Received
    August 3, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RETURN NEEDLE INFILTRATED MID-RINSEBACK. THE CUSTOMER WANTED TO KNOW HOW TO UNLOAD THE TUBING. THE PT WAS DISCONNECTED FROM THE DEVICE. THE OPERATOR WAS INSTRUCTED ON HOW TO CHANGE MODE AND UNLOAD. THE PT INFO IS UNAVAILABLE AT THIS TIME. THE DISPOSABLE IS UNAVAILABLE FOR RETURN. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFO TO DETERMINE IF A MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WHITE BLOOD CELL SET, CLOSED SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNO LKN CARIDIANBCT 05T15223

    Patients

    Seq Age Sex Outcome Treatment
    1