BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA TPE SET

    MDR report key: 2132694 · Received June 7, 2011

    Report

    Report Number
    1722028-2011-00169
    Event Type
    Other
    Date Received
    June 7, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CUSTOMER REPORTS THAT THE PHYSICIAN WAS CONCERNED THAT THE PLATELET COUNT DROPPED AFTER TWO PTS HAD TPE PROCEDURES. THERE WERE NO ALARMS. PT INFO: WEIGHT IS UNAVAILABLE AT THIS TIME. PT RECEIVED A PLATELET TRANSFUSION AS A RESULT OF THE EVENT. PT COMPLETED HER ROUND OF TREATMENT. THE DISPOSABLES ARE NOT BEING RETURNED. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 2

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

    Description of Event or Problem · 2

    THE CUSTOMER REPORTS THAT THE PHYSICIAN WAS CONCERNED THAT THE PLATELET COUNT DROPPED AFTER TWO PTS HAD TPE PROCEDURES. THERE WERE NO ALARMS. PT INFO: DOB AND WEIGHT IS UNAVAILABLE AT THIS TIME. TREATMENT WAS POSTPONED. THE DISPOSABLES ARE NOT BEING RETURNED. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention
    2 Required Intervention