BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 1904581 · Received November 22, 2010

    Report

    Report Number
    2919069-2010-00545
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Removal / Correction Number
    2919069-12/1/09-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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 CUSTOMER STATED THAT THE CELL-DYN WASTE SENSOR IS NOT DETECTING A WASTE FULL. THE CUSTOMER RECEIVED THE FA30NOV2009 LETTER, BUT UNSURE OF THE INSTALLATION DATE OF THE WASTE OUTLET ASSEMBLY. A NEW PART WAS ORDERED FOR REPLACEMENT AND THE CUSTOMER WILL MONITOR THE WASTE (WHILE WAITING FOR THE REPLACEMENT) TO ENSURE IT DOES NOT OVER FLOW. NO EXPOSURE TO HAZARDOUS MATERIAL WAS REPORTED AS THE CUSTOMER WAS WEARING PROTECTIVE EQUIPMENT WHILE CLEANING-UP FLUIDS. NO IMPACT TO PATIENT RESULTS OR PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 WASTE OUTLET TUBE ASSEMBLY