BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3853080 · Received April 2, 2014

    Report

    Report Number
    2028159-2014-00564
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFT 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT A SYSTEM MESSAGE INDICATING THAT THERE WAS LEAKING IN THE INFUSION LINE WAS DISPLAYED DURING SURGERY. NO LIQUID INTO THE MACHINE WAS OBSERVED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200041 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COMBINED PAK 23G 5.000 CUTS PER MINUTE VALVED, 0.9