BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 3221861 · Received July 9, 2013

    Report

    Report Number
    2028159-2013-01393
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AIR CROSSED THROUGH A VALVE INTO THE INFUSION LINE. THE INFUSION LINE WAS CLAMPED TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313185 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1