BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 3875438 · Received June 16, 2014

    Report

    Report Number
    2919069-2014-00033
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. BASED ON THE TICKET INFORMATION, THE LIQUID FROM A LOOSE TYGON TUBING CAME IN CONTACT WITH AN ELECTRICAL COMPONENTS AND CONNECTOR (POWER CORD ATTACHED TO A POWER STRIP) AND CAUSED THE POWER CORD PLUG TO GET DAMAGED (SHORTED) AND GENERATED THE SMOKE AND A BURNING SMELL. THE BURNT POWER CORD WAS REPLACED AND THE BURNING SMELL ISSUE WAS RESOLVED. THERE WAS NO PART RETURN BECAUSE THE CUSTOMER DISCARDED THE POWER CORD WITH A BURNT PLUG. THE POWER STRIP WAS NOT AFFECTED. THERE WAS NO PATIENT OR USER AFFECTED BY THIS INCIDENT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED VISIBLE SMOKE AND A BURNING SMELL COMING FROM THE CELL-DYN SAPPHIRE ANALYZER. NO INJURIES OCCURRED. THE CUSTOMER STATED TUBING WAS POPPING OFF BETWEEN VALVES 143/144 (THE TUBING GOING DOWN FROM THE T-FITTING). NO INSTRUMENT ERRORS HAD BEEN OCCURRING. SERVICE HAS BEEN DISPATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352817 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1