BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA FUNCTIONALLY CLOSED WBC SET

    MDR report key: 1942885 · Received December 21, 2010

    Report

    Report Number
    1722028-2010-00139
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K900105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIN (B)(4). THE SET WAS NOT AVAILABLE FOR EXAMINATION. BACTERIAL CULTURES OF THE KIT BY THE COMPLAINANT WERE POSITIVE FOR GPC. THE PT'S CENTRAL LINE WAS ALSO POSITIVE FOR GPC. MFG AND STERILIZATION RECORDS FOR THIS LOT OF PRODUCT WERE REVIEWED. THERE WAS A PERMIT ECO TO ALLOW THE USE OF PISA BAGS ON THIS LOT, BUT NO OTHER DEVIATION FROM NORMAL MFG WERE NOTED. THE LOT MET ALL MFG AND STERILIZATION PARAMETERS. CONCLUSIONS: THE CAUSE OF THE CONTAMINATION OF THE STEM CELL PRODUCT COULD NOT BE CONCLUSIVELY DETERMINED. FROM THE BACTERIAL CULTURES, THE PT OR HIS CATHETER APPEAR TO BE THE SOURCE OF CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT THEY HAD A POSITIVE CULTURE ON COLLECTED PRODUCT FROM AN AUTOLOGOUS STEM CELL COLLECTION. THE CULTURES WERE POSITIVE FOR (B)(6) AT 5 DAYS POST COLLECTION. THE PT'S CENTRAL LINE WAS REMOVED AND ANTIBIOTICS WERE ADMINISTERED. THIS REPORT IS BEING FILED DUE TO THE POSITIVE BLOOD CULTURES ON THE COLLECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA FUNCTIONALLY CLOSED WBC SET SEPARATOR, AUTOMATED, BLOOD AND PL LKN CARIDIANBCT 07S15281

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other