BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1834262 · Received September 14, 2010

    Report

    Report Number
    2919069-2010-00437
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-4/7/10-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: ASPIRATION BOTTOM SENSOR WORN-OUT FROM NORMAL USE. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED AND THE ISSUE WAS RELATED TO A WORN-OUT PART DUE TO NORMAL USE. A MANDATORY TECHNICAL SERVICE BULLETIN (TSB) IS ISSUED WITH INSTRUCTIONS FOR FIELD SERVICE TO INSPECT AND REPLACE THE PART WHEN NECESSARY. THE PREVENTIVE MAINTENANCE PROCEDURES WILL BE UPDATED IN THE OPERATORS MANUAL TO INCLUDE INSPECTION OF THE ASPIRATION PROBE SENSOR EVERY SIX MONTHS AND REQUEST REPLACEMENT IF REQUIRED. A DESIGN IMPROVEMENT IS IN PROCESS TO IMPROVE THE CABLE AND SEAL THE BOARD AND SWITCH ASSEMBLIES.

    Additional Manufacturer Narrative · 1

    (B)(4). ASPIRATION BOTTOM SENSOR WORN-OUT FROM NORMAL USE. A CORRECTION THROUGH A FOLLOW-UP CORRECTION AND REMOVAL FA01OCT2010 WAS ISSUED TO INCLUDE INSTALLING A NEW SOFTWARE (V4). THE NEW V4 SOFTWARE RELEASED WITH FA01OCT2010 INCLUDES A DESIGN IMPROVEMENT FOR THE ASPIRATION BOTTOM SENSOR. WITH V4, THE CD SAPPHIRE WILL EXECUTE SENSOR CHECKS TO DETERMINE THE STATUS OF THE SENSOR AND WILL GENERATE AN ERROR MESSAGE IF AN ISSUE IS DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S CELL-DYN SAPPHIRE ASPIRATION BOTTOM SENSOR WAS INSPECTED AND REPLACED PER FA05APR2010. THE PART WAS RETURNED FOR INVESTIGATION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ASPIRATION BOTTOM SENSOR (B)(4)