BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA WHITE BLOOD CELL SET, CLOSED

    MDR report key: 2142991 · Received June 21, 2011

    Report

    Report Number
    1722028-2011-00188
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 27, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE PLASMA BAG, AND TUBING BELOW WITH SLIPFIT LUER WERE RETURNED FOR INVESTIGATION. THE BLUE SLIDE CLAMP WAS CLOSED ON THE PLASMA LINE ABOVE THE SLIPFIT LUER. LINE WAS HEATED SEALED BELOW THE LUER. IN THIS CASE BECAUSE THERE WAS NO PRODUCT IN THE PLASMA TUBING ABOVE THE BLUE SLIDE CLAMP, THE LEAK AT THE SLIPFIT LUER POSSIBLY OCCURRED BECAUSE THE CLAMP WAS INADVERTENTLY LEFT CLOSED DURING PLASMA COLLECTION. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PLASMA COLLECTION PROCEDURE, A LEAK BECAME EVIDENT. THE PROCEDURE WAS PAUSED AND THE LINE WITH THE HOLE IN IT WAS CLAMPED AND HEAT SEALED. THE CUSTOMER NOTED A PUNCTURE IN THE LINE. THE PROCEDURE WAS ENDED AFTER RINSE BACK. THE LEAD NURSE INFORMED THE MEDICAL TEAM OF A POTENTIAL SEPSIS ISSUE WITH THE PATIENT. NO MEDICAL INTERVENTION WAS NECESSARY. (B)(4). THIS REPORT IS BEING FILED DUE TO ALLEGED POTENTIAL SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA WHITE BLOOD CELL SET, CLOSED SEPARATOR, AUTOMATED, BLOOD CELL, DIAG LKN CARIDIANBCT 12S15236

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other