BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1894412 · Received November 9, 2010

    Report

    Report Number
    1628664-2010-00408
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE SAMPLING SYRINGE ASSEMBLY MALFUNCTIONED DUE TO LEAKAGE FROM A CRACKED PRESSURE MONITOR SENSOR. THE PRESSURE MONITOR WAS DAMAGED BY THE CUSTOMER DURING THE INSTALLATION OF A SAMPLING PROBE AND THE CUSTOMER DID NOT REPLACE THE DAMAGED, LEAKING PRESSURE SENSOR MONITOR. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER'S OBSERVATION. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND AN INSPECTION AND SERVICING OF THE AXSYM ANALYZER INVOLVED. A FIELD SERVICE REPRESENTATIVE (FSR) NOTED LEAKAGE FROM THE PRESSURE MONITOR AREA HAD DAMAGED THE SAMPLING SYRINGE POWER I/O BOARD . THE FSR REPLACED THE PRESSURE MONITOR SENSOR AND THE SAMPLING SYRINGE ASSEMBLY. PRODUCT LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE POTENTIAL HAZARDS, OPERATIONAL PRECAUTIONS AND LIMITATION. ADDITIONALLY, LABELING INSTRUCTS THE USER TO KEEP ALL LIQUIDS AWAY FROM ALL CONNECTORS OF ELECTRICAL OR COMMUNICATION COMPONENTS. THE SERVICE AND MAINTENANCE MANUAL CONTAINS ADEQUATE INSTRUCTIONS FOR REPLACING AND INSTALLING THE SYRINGE ASSEMBLIES, AS WELL AS, DIRECTIONS TO CHECK CONNECTIONS FOR LEAKS DURING THE INSTALLATION PROCESS. A REVIEW OF THE COMPLAINT TREND REPORTS INDICATED THERE WERE NO ADVERSE TRENDS ASSOCIATED WITH THIS ISSUE. THE EVALUATION REVEALED THE ISSUE WAS NOT THE RESULT OF A NONCONFORMING PART. THERE WAS NO DEFICIENCY IDENTIFIED FOR THE AXSYM ANALYZER, LIST NUMBER 7A83-03, SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SMOKE COMING FROM THE AXSYM ANALYZER AND STATED THEY FELT IT WAS DUE TO A RV CLOG. THE CUSTOMER QUICKLY TURNED OFF THE ANALYZER. FIELD SERVICE INSPECTED THE ANALYZER AND INDICATED THERE WAS A LEAK IN THE SENSOR THAT EFFECTED THE SYRINGE CARD. THERE WAS NO REPORT OF INJURY AND NO MATERIAL DAMAGE RELATED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 PM SENSOR 8G52-01 AND SYRINGE ASSY 4-37072-02