BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1940079 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02443
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF (B)(6) 2009 THROUGH (B)(6) 2010; THIS IS 1 OF 2 EVENTS REPORTED REGARDING THIS ISSUE FOR THIS FACILITY. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DHR AND LOT HISTORY COULD NOT BE REVIEWED. ROOT CAUSE: CONSTELLATION SYSTEM MESSAGE (B)(4) COMPLAINTS HAVE BEEN ATTRIBUTED TO LEAKING CASSETTES/DRAIN BAGS. DRAIN BAGS HAVE SHOWN ACCEPTABLE FUNCTIONAL TEST RESULTS, HOWEVER, WHEN THE DRAIN BAG IS IN THE UPPER RANGE OF THE CRACKING PRESSURE SPECIFICATION (PRESSURE REQUIRED TO OPEN AND ALLOW DRAINAGE IN TO THE DRAIN BAG), LEAKING MAY OCCUR AT THE PUMP ELASTOMER SIGNALING A SYSTEM MESSAGE. ACTIONS TAKEN: AS A PREVENTATIVE MEASURE, ALCON HAS ADJUSTED INVENTORY OF CONFORMING DRAIN BAGS WITH CRACKING PRESSURES IN THE UPPER TOLERANCE ZONE TO CONFORMING DRAIN BAGS WITH CRACKING PRESSURES IN THE LOWER TOLERANCE ZONE. ALCON IS CURRENTLY WORKING WITH THE DRAIN BAG SUPPLIER TO EVALUATE FURTHER ENHANCEMENTS TO THE DRAIN BAG DESIGN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE WAS RECEIVED PRIOR TO BEGINNING A PROCEDURE. THE SYSTEM WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED. THERE WAS A 15 MINUTE DELAY IN THE START OF THE CASE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1