BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3071006 · Received April 2, 2013

    Report

    Report Number
    1722139-2013-00186
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 2, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS NOT RETURNED. CONTACT ATTEMPT WAS MADE TO THE CUSTOMER AND RECEIVED A RESPONSE THAT THE CUSTOMER DID NOT HAVE THE PUMP SERIAL NUMBER BECAUSE PUMP WAS REPLACED BY THE PROVIDER.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A NURSECOMM CALL INDICATES THAT PUMP ALARMS ERROR CODE 13. RATE AND DOSE ARE 43 ML/HR AND 1000 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135487 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR SIMILAC