BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 1972813 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00070
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    December 4, 2007
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD DIAGNOSTICS/CORRECTION: A SERVICE CALL WAS PLACED TO VERIFY THE FUNCTION OF THE EQUIPMENT. A PM WAS PERFORMED AT THE TIME. THERE WERE NO ISSUES FOUND WITH THE EQUIPMENT. INVESTIGATION: INCLUDES RESULTS OF RUN DATA FILE ANALYSIS AND INFO OBTAINED THROUGH CUSTOMER CONTACT. CLOTTING/AGGREGATION OCCURRED IN THE RESERVOIR, OBSCURING THE LOW LEVEL SENSOR RESULTING IN AIR BEING PULLED INTO THE RETURN LINE. THE CUSTOMER WAS USING HEPARIN AS THE ANTICOAGULANT. HEPARIN DOES NOT INHIBIT PLATELET AGGREGATION. CLOTTING DUE TO THE CUSTOMER'S METHOD IN USING HEPARIN WAS THE LIKELY CAUSE OF THE "LOW LEVEL TOO LATE" ALARM. THIS ALARM PROVIDES CAUSE BUTTONS THAT THE OPERATOR SHOULD PRESS TO REVIEW THE POTENTIAL CAUSES AND ACTION TO TAKE TO RESOLVE THE ALARM. FOR THIS ALARM, THE ACTION ADVICE "IF YOU SEE AIR IN THE RETURN LINE, TOUCH DISCONNECT" IS CRITICAL TO AVOID RETURNING AIR IN THE RETURN LINE TO THE PT. THIS ALARM OCCURRED 3 TIMES IN THIS RUN. THE OPERATOR CONTINUED THROUGH EACH OCCURRENCE WITHOUT PRESSING ANY CAUSE BUTTONS TO REVIEW. THE MACHINE ALLOWS THE OPERATOR TO CONTINUE INDEFINITELY PAST ALARMS IN ORDER NOT TO COMPROMISE THE ABILITY TO COMPLETE A PROCEDURE ON A PT. AFTER THE 3RD ALARM, THE OPERATOR DID SCROLL THE ALARM SCREEN TO REVIEW ALL 6 CAUSE BUTTONS BUT DID NOT PRESS ANY OF THE CAUSE BUTTONS TO REVIEW THE ADVICE. THE OPERATOR NOTICED AIR IN THE RETURN LINE, DISCONNECTED THE PT AND ENDED THE RUN. ROOT CAUSE: OPERATOR ERROR. THERE WAS NO ATTEMPT TO RESOLVE THE ALARM CONDITION. CORRECTIVE/PREVENTIVE ACTION: CARIDIANBCT CAPA (B)(4) OUTLINES THE CORRECTIVE AND PREVENTIVE ACTIONS IMPLEMENTED TO ADDRESS THE REPORTED CONDITION.

    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. CUSTOMER RECEIVED HIGH PRESSURE RETURN ALARMS. SHORTLY THEREAFTER THEY ALSO HAD LOWER SENSOR ALARMS THAT HAD CLEARED. THEN THEY NOTICED AIR WAS GOING BACK TO THE PT WITHOUT ALARM. THEY NOTICED THAT THE "BUFFER" OF THE "AIR CATCHER" IN THE BLOOD WARMER WAS "USED UP". OTHERWISE THEY FELT EVEN MORE AIR WOULD HAVE GONE BACK TO THE PT CAUSING A POTENTIALLY SERIOUS INCIDENT. THEY HAD SEEN THAT "SEGMENTS OF AIR" WERE IN THE RETURN LINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK