BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA EXCHANGE SET

    MDR report key: 1972810 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00082
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    June 11, 2009
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPERATOR WAS CALLED TO CHECK ON HER FLUID BALANCE CALCULATION AND MENTIONED THAT THE PT BECAME HYPOTENSIVE DURING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THERE WERE NO ISSUES WITH THE DISPOSABLE OR EQUIPMENT DURING THE PROCEDURE. IN THE SPECTRA OPTIA APHERESIS SYSTEM OPERATOR'S MANUAL (B)(4), POSSIBLE KNOWN ADVERSE EFFECTS OF APHERESIS PROCEDURES ARE LISTED. INCLUDED ON THE LIST ARE HYPOTENSION AND ANXIETY. PER THE OPERATOR'S MANUAL, A BOLUS OF REPLACEMENT FLUID MAY BE GIVEN DURING THE PROCEDURE TO ASSIST THE OPERATOR IN RESPONDING TO PT CONDITIONS SUCH AS HYPOTENSION. THE OPERATOR'S MANUAL ALSO INSTRUCTS USERS TO "MONITOR THE SYSTEM AND THE PT THROUGHOUT THE PROCEDURE." THIS DISPOSABLE SET WAS UNAVAILABLE FOR RETURN OR WAS NOT REQUESTED FOR INVESTIGATION. CONCLUSION: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS, BUT WAS NOT ALLEGED TO HAVE CONTRIBUTED TO THE HYPOTENSIVE REACTION.

    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; THE OPERATOR WAS CALLING THE CARIDIANBCT CLINICAL HELP DESK STAFF TO CHECK HER FLUID BALANCE CALCULATION AND MENTIONED THAT THE PT BECAME HYPOTENSIVE DURING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THERE WERE NO ISSUES WITH THE DISPOSABLE OR EQUIPMENT DURING THE PROCEDURE. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION. THREE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN PT ID.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention