BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2191966 · Received August 4, 2011

    Report

    Report Number
    2919069-2011-00535
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4) - (DEVICE SENSING ISSUE), CUT IN MATERIAL 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. 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 DID NOT DETECT A FULL WASTE AND WASTE ALMOST OVERFLOWED. TROUBLE SHOOTING REVEALED THAT THE WASTE TUBE WAS DAMAGED AND THE SENSOR TERMINAL OF THE WASTE SENSOR IS BROKEN. THE CUSTOMER RECONNECTED THE SENSOR IN A WAY TO TEMPORARILY RESOLVE THE ISSUE. THE WASTE TUBE IS TO BE REPLACED. NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 WASTE OUTLET TUBE ASSEMBLY