BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUTRICIA FLOCARE INFINITY

    MDR report key: 2061041 · Received April 4, 2011

    Report

    Report Number
    1722139-2011-00047
    Event Type
    Other
    Date Received
    April 4, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MMDG FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD MORE INFORMATION BECOME AVAILABLE OR THE PUMP IS RETURNED FOR EVALUATION. THIS DEVICE IS SOLD EXCLUSIVELY TO AN INTERNATIONAL MARKET. THE PUMP IS MANUFACTURED TO SPECIFICATION BY MMDG FOR (B)(4). THE FLOCARE INFINITY PUMP IS SIMILAR TO THE ENTERALITE INFINITY ENTERAL FEEDING PUMP WHICH IS AVAILABLE FOR DISTRIBUTION IN THE UNITED STATES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: FIRST TIME THE PUMP WAS USED. PATIENT WITH PACEMAKER, WHEN THE PUMP WAS SWITCHED ON, THE PATIENT NEARLY FAINTED. HE RECOVERED WHEN THE PUMP STOPPED. THE CARDIOLOGIST SAID IT WAS THE PUMP'S FAULT. POSSIBLY CAUSED BY ELECTROMAGNETIC INCOMPATIBILITY BETWEEN THE PACEMAKER AND OUR PUMP. PATIENT WAS UNDER THE CARE OF A CARDIOLOGIST WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTRICIA FLOCARE INFINITY LZH MOOG MEDICAL DEVICES GROUP FLOCARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK