BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 1952124 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00145
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO TO BE PROVIDED UPON COMPLETION OF EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOR A MNC COLLECTION PROCEDURE, THEY ENTERED A TARGET VALUE OF 200 ML. THE COLLECTED PLASMA VOLUME INCREASED UP TO 440 ML. IT WAS NOT POSSIBLE TO INTERRUPT THE COLLECTION. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR HYPOVOLEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD AND PL LKN CARIDIANBCT 950000005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK