BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 6171840 · Received December 13, 2016

    Report

    Report Number
    1722139-2016-00614
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    September 7, 2016
    Report Date
    November 15, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO MMDG AND EVALUATED. DURING THE INVESTIGATION THE PUMP WAS FOUND TO BE OPERATING WITHIN PRODUCT SPECIFICATIONS. THE COMPLAINT COULD NOT BE VERIFIED OR DUPLICATED. 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 THE PATIENTS STOMACH." MMDG DID NOT MAKE ANY ADDITIONAL ATTEMPTS TO FOLLOW UP, AS THE INITIAL REPORTER HAD STATED THAT THEY WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820988 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL INFUSION PUMP LZH MOOG MEDICAL DEVICES GROUP INFKIT2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR