BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1560824 · Received December 16, 2009

    Report

    Report Number
    2919069-2009-00369
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Date of Event
    November 6, 2009
    Report Date
    November 15, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Removal / Correction Number
    2919069-12/1/09-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), EVALUATION RESULTS (PRODUCT MEETS RELIABILITY DATA).SUSPECT MEDICAL DEVICE: CD 4000 (110V) LN 1H01-01;CD 4000 (220V) LN 1H02-02;CD 4000 (200V) LN 1H03-01;CD 3700 CS ANALYZER LN 2H30-01;CD 3200CS ANALYZER LN 4H59-01;CD 3200 SL ANALYZER LN 4H60-01;CD SMS ANALYZER LN 5H29-04;CD 3500 ANALYZER LN 6H86-04;CD 3700 ANALYZER LN 7H37-01;CD SAPPHIRE ANALYZER LN 8H00-01;CD RUBY ANALYZER LN 8H67-01.THE WASTE OUTLET TUBE ASSEMBLY PART LIFE EXPECTANCY OF 2 YEARS IS NOT CURRENTLY IN OUR PRODUCT LABELING. THE PREVENTIVE ACTION WILL INVOLVE A LABEL CHANGE FOR THE WASTE OUTLET TUBE ASSEMBLY TO HAVE A PART REPLACEMENT SCHEDULE OF 6 MONTHS SO PARTS ARE REPLACED PRIOR TO THE END OF THE 2-YEAR LIFE FAILURE. THIS WILL HELP PREVENT OVERFLOW ISSUES CAUSED BY END OF LIFE PART FAILURE.A TAG THAT CAN BE AFFIXED TO THE WASTE TUBING ITEMS WAS ALSO SENT WITH THE CUSTOMER LETTER. THIS TAG INCLUDES FIELDS TO RECORD INSTALLATION AND REPLACEMENT DATES. TAGS WILL ALSO BE INTRODUCED INTO REPLACEMENT ASSEMBLIES. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EXPANDED INVESTIGATION HAS BEEN CONDUCTED TO EVALUATE THIS ISSUE. THE INVESTIGATION OF THE RETURNED PARTS FROM THE FIELD SHOWED THAT THE PART HAS BEEN IN USE GREATER THAN TWO YEARS. ALTHOUGH, THE WASTE OUTLET TUBE ASSEMBLY MEETS THE RELIABILITY REQUIREMENT, THIS PART WILL WEAR OUT AND THERE EXISTS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WITH LIQUID WASTE WHEN THE WASTE SENSOR FAILS AT THE END OF ITS LIFE CYCLE. THEREFORE; THE PART WILL NEED PERIODIC REPLACEMENT AS IT IS IN CONTACT WITH BIOHAZARD MATERIAL AND CUSTOMER USAGE/HANDLING. THE PART CAN BE USED ON MULTIPLE CELL-DYN INSTRUMENT MODELS. A REVIEW OF THE CELL-DYN SYSTEM OPERATORS MANUALS SHOWED ADEQUATE COVERAGE OF BIOHAZARD EXPOSURE AND WASTE OVERFLOW AS WELL AS TROUBLESHOOTING INFORMATION FOR POTENTIAL CAUSES. ABBOTT RECOMMENDED A REPLACEMENT SCHEDULE FOR THE WASTE LINE ASSEMBLY FOR THE CELL-DYN SYSTEMS. THE WASTE BOTTLE CABLE IS A SUBCOMPONENT OF THE WASTE LINE ASSEMBLY, CHANGING THE WASTE LINE ASSEMBLY WILL RESULT IN CHANGING THE WASTE BOTTLE CABLE. AS PART OF THE CORRECTIVE ACTION, A PRODUCT CORRECTION LETTER, FA30NOV2009, WAS ISSUED TO ALL AFFECTED CUSTOMERS. IN THIS COMMUNICATION, ABBOTT RECOMMENDED REPLACING THE PART EVERY SIX MONTHS. AN UPDATE TO THE PRODUCT LABELING WILL BE ADDED AS WELL WITH REGARDS TO THIS RECOMMENDATION. A TAG THAT CAN BE AFFIXED TO THESE ITEMS WAS SENT WITH THE CUSTOMER LETTER. THIS TAG INCLUDES FIELDS TO RECORD INSTALLATION AND REPLACEMENT DATES. THE TAGS WILL ALSO BE INTRODUCED INTO REPLACEMENT ASSEMBLIES.

    Description of Event or Problem · 1

    THE WASTE LINE ASSEMBLY (LIST NUMBERS 92161-02, 06H54-01), WASTE OUTLET TUBING (LIST NUMBER 02H96-01), AND THE WASTE BOTTLE CABLE (03H98-02) ARE COMPONENTS THAT ARE USED ON ONE OR MORE OF THE CELL-DYN SYSTEMS. DEPENDING ON THE LABORATORY WASTE DISPOSAL REQUIREMENTS, CELL-DYN SYSTEMS CAN BE CONFIGURED WITH AN EXTERNAL WASTE CONTAINER OR WASTE CAN BE ROUTED TO A SUITABLE DRAIN. THIS ISSUE ONLY APPLIES TO LABORATORIES USING AN EXTERNAL WASTE CONTAINER. THE INFORMATION DOES NOT APPLY TO LABORATORIES THAT ROUTE WASTE DIRECTLY TO A DRAIN. OVER TIME, IT IS POSSIBLE FOR THE WASTE LINE ASSEMBLY, WASTE OUTLET TUBING, OR THE WASTE BOTTLE CABLE TO WEAR, WHICH MAY RESULT IN FAILURE OF THE WASTE SENSOR. THIS CAN RESULT IN WASTE LEAKAGE, TUBING LEAKAGE AND/OR OVERFLOW WHEN AN EXTERNAL WASTE CONTAINER IS USED. IN THIS CASE, ABBOTT IS RECOMMENDING THAT THE WASTE LINE ASSEMBLY AND WASTE OUTLET TUBING BE CHANGED EVERY 6 MONTHS. THE WASTE BOTTLE CABLE IS A SUBCOMPONENT OF THE WASTE LINE ASSEMBLY AND WASTE OUTLET TUBING; CHANGING THE WASTE LINE ASSEMBLY OR WASTE OUTLET TUBING WILL RESULT IN CHANGING THE WASTE BOTTLE CABLE. A CUSTOMER COMPLAINT WAS RECEIVED ON SEPTEMBER 14, 2007 REGARDING A WASTE SENSOR FAILURE LEADING TO A WASTE OVERFLOW SPLASH ON THE CELL-DYN 1800. THE COMPLAINT INVESTIGATION WHICH FOCUSED ON THE WASTE OUTLET TUBE ASSEMBLY AND THE WASTE OUTLETUBING DETERMINED THAT THE WASTE SENSOR MET EXPECTATIONS FOR RELIABILITY; HOWEVER, THERE IS A POTENTIAL FOR THE WASTE CONTAINER TO OVERFLOW WHEN THE WASTE SENSOR DOES FAIL (AT THE END OF THE COMPONENTS LIFE), THEREBY CREATING A POTENTIAL EXPOSURE HAZARD. THIS IS A USER-SAFETY ISSUE WITH A POTENTIAL FOR BIOHAZARD EXPOSURE. THERE IS NO IMPACT TO THE PATIENT OR TO PATIENT RESULTS. A PRODUCT CORRECTION WAS ISSUED AND REPORTED UNDER 21 CFR806 TO THE FDA (B)(4) ON NOVEMBER 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 WASTE LINE ASSEMBLY LN 92161-02| WASTE LINE ASSEMBLY LN 92161-02