BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY

    MDR report key: 1850291 · Received October 1, 2010

    Report

    Report Number
    2919069-2010-00465
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 11, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    D019916
    Removal / Correction Number
    2919069-7/26/10-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: CELL-DYN SAPPHIRE ANALYZER, LIST # 8H00, (B)(4). THE CAUSE OF THE CELL-DYN SAPPHIRE VENT NEEDLE ASPIRATION ERROR (UNDETECTED SHORT SAMPLE) WAS DUE TO A DEFECTIVE CELL-DYN VENT NEEDLE FROM THE SUPPLIER. A PRODUCT RECALL INFORMED ABBOTT CUSTOMERS TO DISCARD ANY CELL-DYN SAPPHIRE VENT HEAD ASSEMBLIES AND REPLACE WITH A NEW CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY PROVIDED TO THE CUSTOMER WITH THE CUSTOMER RECALL LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED THE CELL-DYN SAPPHIRE ASPIRATION PROBE FAILED TO HOME. THE CUSTOMER CLEARED THE FAULT MULTIPLE TIMES WITHOUT RESOLUTION. NO OTHER TROUBLESHOOTING WAS PERFORMED BY THE CUSTOMER. THE CUSTOMER WAS INSTRUCTED TO CLEAR THE PATH OF OBSTRUCTION, CLEAR FAULT, ZERO PARK REPLACE THE BENT ASPIRATION PROBE AND VENT HEAD ASSEMBLY, AND RUN SAMPLES IN AUTOLOADER. THE CUSTOMER OBSERVED ONE ADDITIONAL OCCURRENCE OF THE ISSUE AND PERFORMED THE NECESSARY ACTIONS TO RESOLVE THE ISSUE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY VENT NEEDLE USED ON THE CELL-DYN ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 CELL-DYN SAPPHIRE ANALYZER, LIST # 8H00