BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY

    MDR report key: 1801363 · Received August 16, 2010

    Report

    Report Number
    2919069-2010-00382
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    July 19, 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
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: CELL-DYN SAPPHIRE ANALYZER, LIST # 8H00-01, (B)(4). THE CAUSE OF THE CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY 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 VENT HEAD ASSEMBLY PROVIDED TO THE CUSTOMER WITH THE RECALL LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A SHORT SAMPLING FROM THE CELL-DYN SAPPHIRE ANALYZER. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE VENT HEAD NEEDLE BENT AND REPLACED THE VENT HEAD ASSEMBLY AND PROBE. THE FSR PERFORMED VERIFICATION PROCEDURE AND A TEST RUN AND THE ISSUE WAS RESOLVED. 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 8H00-01