BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 1942876 · Received December 21, 2010

    Report

    Report Number
    1722028-2010-00063
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    April 13, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIN (B)(4). RISK ANALYSIS: THERE IS A POTENTIAL FOR SPECTRA OPTIA TO RETURN SMALL AMOUNTS OF AIR TO THE PT THROUGH THE RETURN LINE WHEN THERE IS A SMALL LEVEL OF PLATELET AGGREGATION IN THE RETURN RESERVOIR. THIS AGGREGATION CAN BE CAUSED BY THE USE OF AN INSUFFICIENT LEVEL OF ANTICOAGULATION FOR A GIVEN PT. THE LEVEL OF AGGREGATION MAY BE INSUFFICIENT TO ACTIVATE THE ALARMS. FIELD DIAGNOSTIC/CORRECTION: (B)(6), VISITED THE CUSTOMER SITE TO DISCUSS THE INCIDENT. THE CAUSE OF THE ISSUE IN THIS CASE WAS FOUND THROUGH THE RDF ANALYSIS TO BE A CLOT IN THE FILTER, WHICH IS A PT AND PROCEDURALLY RELATED PROBLEM RATHER THAN AN EQUIPMENT ISSUE. A PM WAS PERFORMED ON THIS EQUIPMENT ONLY TWO WEEKS PRIOR TO THIS INCIDENT WITH NO ISSUES FOUND. INVESTIGATION: RDF ANALYSIS VERIFIED PLATELET CLUMPING BEGAN AT 10 MINUTES INTO THE PROCEDURE AND CONTINUED TILL THE PROCEDURE WAS DISCONTINUED. THE WORST CASE SCENARIO DETERMINED FOR THE AMOUNT OF AIR RETURNED WAS 21 MLS OVER 54 MINUTES. BASED ON THE RUN DATA FILE ANALYSIS IT IS LIKELY THAT A BLOOD CLOT BLOCKED THE LOW LEVEL SENSOR CAUSING A FALSE FLUID READING. THIS CAUSED THE FLUID LEVEL TO GO BELOW THE SENSOR ALLOWING AIR TO BE DRAWN INTO THE RETURN LINE. CONCLUSION: A CLOT IN THE FILTER BLOCKED THE LEVEL SENSOR ENOUGH TO CAUSE AIR TO BE DRAWN INTO THE RETURN LINE. CORRECTIVE ACTION: SOFTWARE WAS ENHANCED TO MOVE CAUSE TEST FOR CHECKING FOR OBSTRUCTIONS UP TO THE FIRST SCREEN. SOFTWARE ALSO LIMITED THE NUMBER OF TIMES THE OPERATOR COULD CONTINUE. ADDITIONALLY A SAFETY ALERT AND TRAINING WAS PROVIDED TO CUSTOMERS REGARDING THE IMPORTANCE OF ADEQUATE ANTICOAGULATION.

    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. DURING USE: APPROACHING END OF RUN THE OPERATORS SAW AIR INSIDE THE RETURN LINE. THEY IMMEDIATELY PAUSED THE PROCEDURE. ORIGIN OF PROBLEM WAS MANY AGGREGATE AROUND RESERVOIR FILTER. THIS PARTICULAR PT IS A KNOWN "CLUMPER" AND WILL CLOT OFF COBE SPECTRA ON OCCASION. THE CENTER USES 20% ALBUMIN AS THEIR REPLACE FLUID AND THEY DILUTE DOWN TO 4-5% IN A SINGLE BAG OF SALINE, WHICH THEY FEEL LEAVES THEM AT A NEGLIGIBLE AMOUNT OF ACDA IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 61000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other