BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOCARE INFINITY

    MDR report key: 5485022 · Received March 7, 2016

    Report

    Report Number
    1722139-2016-00156
    Event Type
    Death
    Date Received
    March 7, 2016
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    N/A-FOREIGN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE FLOCARE INFINITY ENTERAL PUMP IS MANUFACTURED EXCLUSIVELY FOR EXPORT TO NUTRICIA, A FIRM LOCATED IN THE UNITED KINGDOM, AND IS NOT DISTRIBUTED IN THE UNITED STATES, MMDG IS SUBMITTING THIS MDR BASED ON THE SIMILARITY IN THE DESIGN AND MANUFACTURE OF FLOCARE INFINITY AND ENTERALITE INFINITY PUMPS. THE INVESTIGATION DONE BY THE BRITISH POLICE DEPARTMENT IN WORCESTERSHIRE SHOWS THAT NO ABNORMALITY WAS FOUND IN THE DEVICE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER, SO A PROPER EVALUATION OF THE CAUSE OF THE LEAK HAS NOT YET BEEN POSSIBLE. MOOG WILL UPDATE THIS REPORT WITH NEW INFORMATION AS IT BECOMES AVAILABLE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE DEATH OF AN INFANT WAS REPORTED TO NUTRICIA BECAUSE AT THE TIME OF THE EVENT A FLOCARE INFINITY PUMP WAS BEING USED TO FEED THE INFANT IN THE INFANT'S HOME. NUTRICIA SUBSEQUENTLY REPORTED THE EVENT TO MMDG. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141050 FLOCARE INFINITY ENTERAL INFUSION PUMP LZH MOOG MEDICAL DEVICES GROUP FLOCARE INFINITY NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death