BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SET, 500ML, ENTERALITE

    MDR report key: 5503118 · Received March 15, 2016

    Report

    Report Number
    1722139-2016-00367
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    July 2, 2014
    Report Date
    March 15, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    PIO
    PMA / PMN Number
    K142539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT RETURNED THE DEVICE FOR EVALUATION TO MOOG MEDICAL DEVICES GROUP (MMDG) IN UTAH. MMDG SENT THE DEVICE VIA FEDEX TO MOOG MEDICAL DEVICES GROUP, SRL IN COSTA RICA. DURING TRANSIT THE DEVICES WERE INADVERTENTLY LOST.

    Description of Event or Problem · 1

    CUSTOMER STATES: CARE GIVER STATES THE INF0500 SETS WITH LOT # CF1401704 ARE PUMPING AIR AND NOT LETTING FORMULA GO THROUGH BUT AIR ONLY, PUMP DOES NOT ALARM. CARE GIVER WILL CHANGE THE SET AND THE FEEDING WILL BE COMPLETED WITHOUT PROBLEMS. THREE PUMPS HAVE BEEN EXCHANGED AND ALL THREE HAVE PASSED THE RAPID CHECK PROCEDURE TEST, SN (B)(4), THIS LAST PUMP WAS TESTED AND PASSED TEST BEFORE IT WAS GIVEN TO THE PATIENT. CUSTOMER WOULD LIKE AN INVESTIGATION AS BELIEVED TO BE USERS ERROR BECAUSE PUMPS PASS ALL TESTING WITHOUT PROBLEMS. PUMPS ARE NOW WITH OTHER PATIENTS AFTER PASSING ALL TESTING AND THE PUMPS ARE WORKING WITH NO PROBLEMS AT ALL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157999 BAG SET, 500ML, ENTERALITE ENTERAL FEEDING SET PIO MOOG MEDICAL DEVICES GROUP INF0500 CF1401704

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR NEOCATE JR