BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA WHILE BLOOD CELL SET, CLOSED

    MDR report key: 2211361 · Received August 4, 2011

    Report

    Report Number
    1722028-2011-00258
    Event Type
    Other
    Date Received
    August 4, 2011
    Date of Event
    May 6, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE COLLECT BAG AND THE LINE FROM A SPECTRA SET WERE RETURNED FOR INVESTIGATION. DRIED BLOOD WAS NOTED AROUND THE SLIP FIT LUER. WHEN STRIPPING THE LINE AS THE CUSTOMER DID, A LEAK WAS OBSERVED AT THE SLIP FIT LUER. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE CELL COLLECTION WAS DONE, THE NURSE PREPARED THE LEUKOCYTE BAG IN ORDER TO SEND IT TO THE CELLULAR THERAPY LAB. WHEN STRIPPING THE COLLECT TUBING OF THE BAG, THERE WAS AN ALLEGED LEAK IN THE TUBING. CELLS SPILLED ONTO THE NURSE'S OUTFIT. THE DOCTOR WAS INFORMED AND DECIDED THAT THE BAG WOULD NOT BE SENT TO THE CELLULAR THERAPY LAB. RE-INJECTION OF THE CELLS WAS NOT DONE. THE DONOR'S INFO IS PROVIDED IN SECTION A. THE DONOR'S WEIGHT IS NOT AVAILABLE AT THIS TIME. THE NURSE'S INFO IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY FROM BLOOD EXPOSURE AND UNK CELLULAR THERAPY OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WHILE BLOOD CELL SET, CLOSED SEPARATOR, AUTOMATED, BLOOD CELL, DIAG LKN CARIDIANBCT 01T15295

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other