BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1651424 · Received March 30, 2010

    Report

    Report Number
    1722139-2010-00037
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 8, 2010
    Report Date
    March 29, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS EVALUATED. RESULTS: THE EVALUATION INCLUDED PERFORMANCE TESTING (ACCURACY, VERIFICATION OF AIR/NO FOOD ALARM, ETC.). MULTIPLE FORMULAS WERE USED AT SETTINGS (RATE AND DOSE) OBTAINED FROM THE PUMP SOFTWARE LOG TO RECREATE THE FAILURE EXPERIENCED BY THE CUSTOMER. THE PUMP PERFORMED ACCORDING TO SPECIFICATION DURING EACH RUN (ALARMED AND SHUT OFF AFTER FOOD WAS GONE). CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. WE ARE ATTEMPTING TO CONTACT THE CUSTOMER/PATIENT TO OBTAIN MORE INFORMATION. IF MORE CUSTOMER/PATIENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: PUMP CONTINUED TO PUMP AFTER FOOD WAS GONE. CUSTOMER STATED "UNIT DID NOT ALARM WHEN DOSE WAS FINISHED THE PUMP CONTINUED TO RUN." NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1