BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2132750 · Received June 10, 2011

    Report

    Report Number
    1722139-2011-00094
    Event Type
    Other
    Date Received
    June 10, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE OCCLUSION ALARM FUNCTION OF THE PUMP WAS TESTED AND FOUND TO BE WORKING AS EXPECTED. EACH TIME AN UPSTREAM OR DOWN STREAM OCCLUSION WAS INTRODUCED THE PUMP ALARMED AS EXPECTED. FURTHER EVAL OF THE PUMP EVENT LOG SHOWED AN OCCLUSION ALARM HAD OCCURRED INDICATING AN OCCLUSION HAD OCCURRED. FROM THE LOG FILE, WE COULD ALSO READ THAT THE PRIME FUNCTION WAS USED DIRECTLY FOLLOWING THIS OCCLUSION EVENT. USING THE PRIME FUNCTION WHILE WITHOUT CLEARING AN OCCLUSION IS AGAINST THE INSTRUCTIONS OF USE (IFU) AS THIS WILL RE-CALIBRATE THE OCCLUSION ALARM PARAMETERS OF THE PUMP. THE USER QUITE LIKELY TRIED TO OVERCOME THE OCCLUSION SITUATION BY USING THE PRIME FUNCTION AND DID NOT RESOLVE THE OCCLUSION AS MENTIONED IN THE PRODUCT IFUS. CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. THE PUMP PERFORMED ACCORDING TO SPECIFICATION. THIS DEVICE IS SOLD TO AN INTERNATIONAL MARKET; HOWEVER, IT IS SIMILAR TO THE ENTERALITE INFINITY ENTERAL FEEDING PUMP WHICH IS AVAILABLE FOR DISTRIBUTION IN THE U.S.

    Description of Event or Problem · 1

    CUSTOMER REPORTED; THE NURSE SET THE DOSE TO 100 ML AND THE RATE AT 100 ML/HR WHEN SHE CAME BACK AN HOUR LATER NOTHING HAD DELIVERED. THE SET TUBING HAD MILK CLOGGING THE TUBING. PT INJURY OR MEDICAL INTERVENTION: NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK