BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 1972808 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00129
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    September 30, 2010
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLETE OPTIA SET WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE SET NO MIS-ASSEMBLES OR DEFECTS WERE NOTED WITH THE SET. COLD AGGLUTININ DISEASE IS CHARACTERIZED BY THE PRESENCE OF HIGH CONCENTRATIONS OF CIRCULATING ANTIBODIES DIRECTED AGAINST RED BLOOD CELLS. IT IS COMMON TO HEAT THE TREATMENT ROOM WHEN PERFORMING TPE ON PTS WITH COLD AGGLUTININ DISEASE. THE TREATMENT ROOM WAS NOT HEATED FOR THIS TREATMENT. CONCLUSION: THE PT'S DISEASE STATE CONTRIBUTED TO THIS INCIDENT. THE SPECTRA OPTIA APPEARED TO BE OPERATING CORRECTLY.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. ONE TIME, DURING PROCEDURE, DURING A TPE ON A PT WITH COLD AGGLUTININS, OPERATOR NOTICED SOMETHING IN THE RETURN LINE, AFTER THE RETURN CHAMBER THAT LOOKED LIKE CLOTTING. THERE WERE SWIRLS OF SOMETHING IN THE RETURN CHAMBER THAT THEY THOUGHT HAD PASSED THROUGH THE FILTER. OPERATOR ABORTED THE RUN AFTER 800ML OF EXCHANGED PLASMA, WITHOUT PERFORMING RINSEBACK. AFTER UNLOAD OF THE DISPOSABLE SET THEY COULDN'T SEE ANYTHING IN THE RETURN LINE BUT STILL SOMETHING IN THE RETURN CHAMBER. OPERATORS DIDN'T USE AN EXTRA HEATED ROOM, ONLY NORMAL ROOM TEMPERATURE. THEY USED WARM FLUIDS DURING THE RUN. DISPOSABLE IS AVAILABLE FOR INVESTIGATION. THIS REPORT IS BEING FILED AS A RESULT OF MEDICAL INTERVENTION TO END THE TREATMENT EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT NA 06S3121

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R