BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 1834395 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01442
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    May 28, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE FOR THIS FACILITY. THERE ARE NO ADDITIONAL COMPLAINTS REPORTED AGAINST THE FINISHED GOOD LOT. THE ORDER WAS BUILT AND RELEASED PER SPECIFICATION. ONE 23GA PAK WAS RETURNED, WITHOUT THE ADMINISTRATION AND THE PROBE LINES. THE DEVICE WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. ADMINISTRATION AND THE PROBE LINES, TAKEN FROM LAB STOCK, WERE CONNECTED TO THE HOUSING AND THE SAMPLE WAS TESTED USING THE CONSOLE. THE SAMPLE PRIMED AND PASSED IOP CALIBRATION SUCCESSFULLY. THE FLUIDICS PORTION OF THE TESTING WAS PERFORMED AND THE RESULTS WERE WITHIN SPECIFICATION; HOWEVER, WHEN ATTEMPTING TO TOGGLE THE INFUSION AND THE FLUID/AIR EXCHANGE (F/AX) MODES, NO AIR PRESSURE FLOWED TO THE INFUSION AIR LINE. THE INFUSION LINE WAS REMOVED FROM THE HOUSING AND PERFORMED AIR PRESSURE TEST USING THE MENSOR. IT WAS OBSERVED THAT THE DUCKBILL CHECK VALVE WAS NOT ACTUATING PROPERLY TO ALLOW AIR FLOW. ROOT CAUSE: DUCK BILL CHECK VALVE NOT ALLOWING AIR FLOW. QUALITY ASSURANCE WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO IMPACT, HARM OR INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "CASSETTE DOES NOT ALLOW TO PERFORM THE FLUIDIC EXCHANGE" (DEVICE OPERATES DIFFERENTLY THAN EXPECTED). THE CASSETTE DOES NOT ALLOW TO PERFORM THE FLUIDIC EXCHANGE. THERE WAS NO PATIENT IMPACT AND THE DELAY GENERATED (TO CHANGE THE CASSETTE) WAS AROUND 15 MINUTES ADDED TO A NORMAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION 921562H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION CUSTOM PAK