BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA SEAL SAFE

    MDR report key: 2111524 · Received May 17, 2011

    Report

    Report Number
    1722028-2011-00118
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SEAL SAFE UNIT SPARKED AND THEN THE RF BOX CAUGHT ON FIRE. THE LOCAL FIRE DEPARTMENT WAS CALLED TO THE SCENE. NO ONE WAS INJURED IN THIS INCIDENT; NO TREATMENTS OR MEDICATIONS WERE REQUIRED. THE PT AGE AND WEIGHT ARE NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA SEAL SAFE SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 71200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other