BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 4000 220V ANALYZER

    MDR report key: 1220924 · Received November 7, 2008

    Report

    Report Number
    2919069-2008-00768
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K961439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ON (B)(6) 2008, (B)(6) HOSPITAL IN (B)(6) REPORTED THAT THE WHITE BLOOD CELL (WBC) REAGENT HEATER CIRCUIT BOARD HAD FAILED AND CHARRED WITH SMOKE ON THE CELL-DYN 4000 INSTRUMENT. THE CABLE TO THE BOARD HAD MELTED. THE CUSTOMER TECHNICAL ADVOCATE (CTA) CONFIRMED THAT THE CUSTOMER HAD REPLACED THE WBC MIXPOT ON (B)(6) 2008, AND THAT THE WBC REAGENT HEATER CIRCUIT FAILED AND DAMAGED THE CABLE AS WELL. THE CUSTOMER REQUESTED A NEW PART FOR REPLACEMENT. THE CTA DISPATCHED A TECHNICAL SUPPORT SPECIALIST (TSS) TO INVESTIGATE THE ISSUE WITH THE CELL-DYN 4000 INSTRUMENT. ON (B)(6) 2008, THE TSS FOUND THAT THE WBC REAGENT HEATER OVERHEATED DAMAGING THE MAIN PCB AND CABLE. THE SAMPLE PROBE WAS OUT OF ALIGNMENT. THE CAUSE OF THE ISSUE WAS DUE TO LIQUID IN THE CABLE CONNECTION WHICH OCCURRED WHEN THE CUSTOMER CHANGED OUT THE CABLE ON (B)(6) 2008. THE TSS REPLACED THE WBC REAGENT HEATER AND THE HOTPOT CONTROLLER MODULE COMPLETE WITH CABLE, PERFORMED SAMPLE PROCESSOR AND AUTO LOADER ALIGNMENT, RAN CELL-DYN 29 PLUS CONTROL, LOT # 82389 AND RETURNED THE SYSTEM TO OPERABLE STATUS. THE CELL-DYN 4000 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 01H25-01, REVISION M, UNDER SECTION 8, HAZARD INFORMATION AND PRECAUTIONS, GENERAL ELECTRICAL HAZARD INFORMATION, PAGE 8-5, RECOMMENDS TO KEEP LIQUIDS AWAY FROM ALL ELECTRICAL CONNECTORS (SUCH AS ELECTRICAL OUTLETS). A REVIEW OF THE COMPLAINT TRENDING SYSTEMS FOR THE PERIOD (B)(6) 2007 THROUGH (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 4000, LIST 01H02-01 FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 4000 FOR THE REPORTED ISSUE. THERE WAS NO SYSTEMIC ISSUE FOR THE CELL-DYN 4000 PRODUCT LINE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER INSTALLED A NEW WBC REAGENT HEATER ON THE CELL-DYN 4000 ANALYZER. NEXT DAY, THE CUSTOMER OBSERVED SMOKE COMING OUT OF THE NEWLY INSTALLED WBC REAGENT HEATER. UPON TROUBLESHOOTING, IT WAS DISCOVERED THAT THE WBC REAGENT HEATER CIRCUIT BOARD OVERHEATED, SUBSEQUENTLY DAMAGING THE CABLE CONNECTED TO THE BOARD. A SERVICE CALL WAS INITIATED. THERE WAS NO INJURY DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 220V ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1