BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED SYSTEM APHERESIS KIT W/ RESTRICTOR TUBING

    MDR report key: 870210 · Received June 20, 2007

    Report

    Report Number
    2648979-2007-00001
    Event Type
    Malfunction
    Date Received
    June 20, 2007
    Date of Event
    June 15, 2007
    Report Date
    June 15, 2007
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    Removal / Correction Number
    2007-0035-TT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNUSED COMPLAINT PRODUCT WAS RECEIVED AND WAS AUTOPSIED TO CONFIRM THE CUSTOMER'S REPORT OF DISASSEMBLY OF THE ACD & SALINE TUBES WITHIN THE MONITOR BOX. THE ABOVE DEFECT WOULD NOT BE DETECTED BY THE INSTRUMENT DURING PRIME AND COULD RESULT IN KIT USE IF NOT DETECTED PRIOR TO DONOR CONNECT. AN OPERATOR MAY NOTICE THE FOLLOWING FACTORS AND DISCONTINUE USE: 1. THE CS3000 MANUAL REQUIRES THE ACD DRIP RATE BE MONITORED TO DETERMINE THE RATIO OF ACD TO WHOLE BLOOD. THE MANUAL LISTS EXPECTED DRIP RATES (APPROXIMATE DROPS/MIN). IF THE ACD AND SALINE SOLUTION TUBES ARE SWITCHED, DUE TO THE LARGER TUBING ON THE WHOLE BLOOD PUMP TUBING, THE ACD FLOW WILL BE A STREAM RATHER THAN DROPS AND READILY APPARENT AS ABNORMAL. 2. AN OPERATOR MAY NOTICE UNUSUAL RATES OF DEPLETION OF THE SOLUTIONS: ACD SOLUTION RAPIDLY DEPLETED, AND THE SALINE BAG NOT DEPLETED. 3. LATER IN THE PRIME STEPS, THE SALINE BAG IS INFLATED AS EXCESS FLUID AND AIR IS EXPRESSED OUT OF THE KIT AND INTO THE BAG. THE AFFECTED LOT WAS MANUFACTURED IN AUGUST 2006. A QDS COMPLAINT QUERY WAS PERFORMED FOR THE TIMEFRAME NOVEMBER 2005 THROUGH MAY 2007. NO COMPLAINTS RELATED TO SWITCHED SOLUTION BAGS ON CS3000 KITS WERE IDENTIFIED. THE OCCURRENCE OF AFFECTED UNITS WITHIN THE LOT IS EXPECTED TO BE LOW AS ALL IN-PROCESS AND FINAL RELEASE FUNCTIONAL AND PHYSICAL TESTS, WHICH SHOULD DETECT ANY ASSEMBLY ERROR, WERE PERFORMED PER ESTABLISHED AQLS AND PASSED. A BATCH RECORD REVIEW IDENTIFIED NO ISSUES DURING PRODUCTION. THE HEALTH HAZARD ASSOCIATED WITH SWITCHED SOLUTION BAGS IS EXCESSIVE ACD INFUSION. THE PROBABLE CAUSE OF THIS DEFECT IS MANUFACTURING ERROR. BASED ON THE RESULTS OF THE INVESTIGATION, A RECALL WAS INITIATED TO ALL CUSTOMERS ON 6/20/2007 VIA DIRECT CALL TO ALL KNOWN PURCHASERS OF SIMILAR CS3000 KITS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED NOTING BEFORE USE, THE SALINE (PRIME) TUBING FROM THE MONITOR BOX CONNECTED TO THE ACD (ANTICOAGULANT) BAG ASSEMBLY AND THE ACD TUBE COMING FROM THE MONITOR BOX CONNECTED TO THE SALINE BAG ASSEMBLY. THERE WAS NO DONOR ISSUE REPORTED WITH THIS EVENT. THE AFFECTED LOT WAS MANUFACTURED IN AUGUST OF 2006 WITH NO SIMILAR REPORTS RECEIVED PRIOR TO THIS REPORT. THE POTENTIAL ADVERSE EVENT ASSOCIATED WITH REPORTED MISASSEMBLY IS POSSIBLE EXCESSIVE ACD INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSED SYSTEM APHERESIS KIT W/ RESTRICTOR TUBING CS3000 APHERESIS KIT GKT FENWAL, INC. NA N06H03027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other