BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPE SET, SPECTRA

    MDR report key: 1951901 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00121
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    July 3, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)() - POSSIBLE HEMOLYSIS. THE CARIDIANBCT CLINICAL SPECIALIST REQUESTED THAT THE OPERATOR PAUSE THE PROCEDURE AND THEN TO STOP THE CENTRIFUGE WHILE ATTEMPTING TO TROUBLESHOOT. ALL FLUIDS WERE DOUBLE CHECKED AND WERE CORRECT. A FEMORAL CATHETER WAS BEING USED FOR THE PROCEDURE. THE INLET AND RETURN LINE ARE CONNECTED TO THE CORRECT CATHETER PORT. THE HEMATOCRIT ENTERED WAS CORRECT. THE FFP WAS O POS AND THE PT'S BLOOD TYPE IS O POS. THE OPERATOR TOOK A SAMPLE FROM BOTH PORT OF THE CATHETER TO COMPARE AND THEY BOTH APPEARED TO BE THE SAME COLOR. THE CARIDIANBCT CLINICAL SPECIALIST SUGGESTED THAT THE OPERATOR TAKE A SAMPLE FOR HEMATOCRIT FROM ACCESS AND RETURN PORTS ON THE TUBING SET WITH CLAMPS TO PT CLOSED TO DETERMINE IF BLOOD WAS HEMOLYZING IN THE SYSTEM. THIS DISPOSABLE SET WAS UNAVAILABLE FOR RETURN FOR INVESTIGATION. CONCLUSION: THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE PT'S DISEASE STATE. THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP). THE DISPOSABLE SET WAS UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QUALITY ASSURANCE: CUSTOMER REPORTED THAT THE BLOOD IN THE CENTRIFUGE LOOKED "CHERRY" RED AND THE OPERATOR WAS UNABLE TO VISUALIZE THE INTERFACE WHEN PERFORMING A TPE PROCEDURE. THE BLOOD IN THE WASTE BAG AND PLASMA LINE LOOKED TEA COLORED. THE BLOOD IN THE RBC AND RETURN LINES WERE VERY LIGHT RED AND TRANSLUCENT AS IF NO CELLS ARE PRESENT. THERE DO NOT APPEAR TO BE CELLS IN THE REMOVE BAG. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR PT INJURY AS A RESULT OF HEMOLYSIS. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN PT IDENTIFIER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPE SET, SPECTRA SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT NA 11R15235

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention