BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2860313 · Received November 21, 2012

    Report

    Report Number
    1722139-2012-01188
    Event Type
    Other
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP LOG SHOWS TWO OCCLUSIONS WITH AN ALARMS. THERE IS NO EVIDENCE FROM THE LOG THAT THE SET WAS REMOVED FROM THE PUMP TO CLEAR EITHER OCCLUSION BEFORE ANOTHER THERAPY WAS STARTED. FAILURE TO CLEAR THE OCCLUSION RESULTED IN THE PUMP INDICATING VOLUME WAS BEING DELIVERED WHEN IT DID NOT, DUE TO THE OCCLUSION. ATTEMPTS WERE MADE TO OBTAIN PATIENT INVOLVEMENT WITH NO RESPONSE. A FOLLOW UP WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DISTRIBUTOR ALLEGED THEY RECEIVED A COMPLAINT THAT A YOUNG CHILD WAS HOSPITALIZED ON USING THE PUMP. THE ALARM DOESN'T TRIGGER EVEN IF THE NUTRITION WAS NOT ADMINISTRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP FLOCARE PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization