BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 1172586 · Received September 19, 2008

    Report

    Report Number
    2028159-2008-00345
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE VACUUM PRESSURE MANIFOLD AND RECEIVE MECHANISM FOR VACUUM/PRIMING ISSUES. THE VACUUM PRESSURE MANIFOLD AND RECEIVER MECHANISM WERE SENT IN HOUSE FOR TESTING. THE SYSTEM WAS TESTED AND IT MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT ABOUT HALF WAY THROUGH THE CASE, THE UNIT BEGAN LEAKING FLUID AND THERE WAS POOR VACUUM. THE CIRCULATOR HAD TO SCRUB IN TO MANUALLY VACUUM WITH A SYRINGE WHILE THE SURGEON WAS PERFORMING THE PROCEDURE. THE CASE WAS EXTENDED BY AT LEAST AN HOUR. THEY REBOOTED AND THEN THE SYSTEM WOULD NOT PRIME. THE SURGEON COMPLETED THE CASE MANUALLY. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI