BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 1913706 · Received November 12, 2010

    Report

    Report Number
    2028159-2010-02194
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION AND ROOT CAUSE ANALYSIS. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED, THIS IS 1 OF 10 COMPLAINT REPORTS OF THIS NATURE (PRODUCT LEAKING) REPORTED BY THIS ACCOUNT. A REVIEW OF THE DHR INDICATED NO DEVIATIONS. THE FINISHED GOODS LOT WAS RELEASED PER SPECIFICATION. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS INVESTIGATION, FUNCTIONAL TESTING FOR ROOT CAUSE DETERMINATION COULD NOT BE PERFORMED. THE REPORTED SYSTEM MESSAGES 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 SPECIFICATIONS (PRESSURE REQUIRED TO OPEN AND ALLOW DRAINAGE IN TO THE DRAIN BAD), LEAKING MAY OCCUR AT THE PUMP ELASTOMER SIGNALING A SYSTEM MESSAGE. ALCON HAS ADJUSTED INVENTORY OF CONFORMING DRAIN BAGS WITH CRACKING PRESSURES IN THE UPPER TOLERANCE ZONE TO CONFORMING DRAIN BAGS WITH CRACKING PRESSURE IN THE LOWER TOLERANCE ZONE. ALCON IS CURRENTLY WORKING WITH THE DRAIN BAG SUPPLIER TO EVALUATE FURTHER ENHANCEMENTS TO THE DRAIN BAG DESIGN. QUALITY ASSURANCE WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: THAT DURING SURGERY IT WAS NOTICED THAT THE BSS WAS LEAKING FROM THE CASSETTE, THIS DID NOT INTERRUPT THE SURGERY AND MACHINE CONTINUED TO WORK, SURGERY WAS COMPLETE WITHOUT ANY PT HARM. THEY TOOK THE CASSETTE OUT AT THE END OF SURGERY AND NOTICED LOTS OF WATER BEHIND THE CASSETTE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION SURGICAL PAK