BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANIFOLD

    MDR report key: 2023222 · Received February 16, 2011

    Report

    Report Number
    2023222
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPARENTLY IN THE ICU, THE DEVICE HAD BEGUN LEAKING AT THE STOPCOCK AFTER THE PROPOFOL HAD BEEN INFUSING FOR SEVERAL HOURS. THIS HAS OCCURRED WITH MULTIPLE DEVICES. WE DID NOT SEND THE DEVICES BACK TO MANUFACTURER BECAUSE STAFF DID NOT SAVE THEM. HOWEVER, PRELIMINARILY THE COMPANY STATES THAT THEY DON'T BELIEVE THE DEVICE IS MADE FOR LIPIDS, THOUGH IT DOESN'T STATE THAT ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANIFOLD 4 GANG MANIFOLD DTL EDWARDS LIFESCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * OTHER