BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYS

    MDR report key: 3960026 · Received May 29, 2014

    Report

    Report Number
    2028159-2014-00932
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOSP PHARMACIST REPORTED THAT DURING A VITRECTOMY SURGERY, THE AUTO-STABLE INFUSION WAS NOT FUNCTIONING ON THE PAK. THE PAK WAS EXCHANGED AND THE INFUSION FUNCTIONED CORRECTLY. THE SURGERY WAS COMPLETED WITHOUT ANY PT HARM. ADDITIONAL INFO WAS RECEIVED FROM THE OPERATING ROOM SUPERVISOR WHO REPORTED THAT THE SAME EVENT OCCURRED TWICE DURING TWO DIFFERENT SURGERIES. THE SUPERVISOR ALSO CLARIFIED THE EVENT INFORMING THAT THE DIAMETER OF INFUSION CABLE WAS TOO SMALL COMPARED TO THE DIAMETER OF THE VALVED TROCAR AND THE INFUSION CABLE COULD GET OFF THE EYE AT ANY MOMENT DURING THE SURGERY. A NEW PAK HAD TO BE OPENED TO COMPLETE THE SURGERY. THE SAME ACTION WAS TAKEN ON BOTH SURGERIES. BOTH SURGERIES WERE COMPLETED WITHOUT ANY PT HARM. THERE ARE TWO MED DEVICE REPORTS BEING FILED FOR THIS FACILITY. THIS REPORT IS FOR THE EVENT THAT OCCURRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315572 CONSTELLATION VISION SYS UNIT, PHACOFRAGMENTATION HQC ALCON -IRVINE TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS PAK, 25+ 5.0 CPM STD