BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 6096538 · Received November 11, 2016

    Report

    Report Number
    1722139-2016-00596
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO MMDG AND THE PUMP EVALUATED FOR THE COMPLAINT. MMDG WAS UNABLE TO REPLICATE OR CONFIRM THE COMPLAINT. THIS COMPLAINT OCCURRED WHILE THE DEVICE WAS IN USE WITH A PEDIATRIC PATIENT. WHILE NO HARM OR ADVERSE EFFECT TO THE PATIENT WAS REPORTED MMDG CONSIDERS ALL INSTANCES OF OVERRUN WITH A PEDIATRIC PATIENT REPORTABLE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT THE PUMP IS "PUMPING AIR INTO PATIENT'S STOMACH." MMDG DID FOLLOW UP WITH THE INITIAL REPORTER AND THEY STATED THAT THEY DID NOT HAVE ANY ADDITIONAL INFORMATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746185 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL INFUSION PUMP LZH MOOG MEDICAL DEVICES GROUP INFKIT2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT PROVIDED