BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 2121937 · Received June 1, 2011

    Report

    Report Number
    1722028-2011-00148
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT 30 MINUTES INTO A PMN PROCEDURE, THE DONOR HAD A LARGE INFILTRATION IN THE ARM. THE NURSE STOPPED THE PROCEDURE. THERE WAS NO RETURN PRESSURE ALARM DURING THE PROCEDURE. THE NEEDLE WAS REMOVED AND A NEW PROCEDURE BEGUN IN A DIFFERENT LOCATION ON THE ARM. AFTER REMOVING THE NEEDLE, THEY APPLIED HEAT ON THE INFILTRATED AREA AND ALSO MASSAGED THE BICEPS AREA. THE DONOR WAS INSTRUCTED TO APPLY HEAT AND TAKE ANTI-INFLAMMATORY MEDICATION FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 950000000

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R