BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 15123069 · Received July 28, 2022

    Report

    Report Number
    1722139-2022-00739
    Event Type
    Death
    Date Received
    July 28, 2022
    Date of Event
    June 29, 2022
    Report Date
    June 29, 2022
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO MMDG FOR EVALUATION. A DHR WAS COMPLETED AND FOUND NO NON-CONFORMANCES. WHEN THE DEVICE WAS RETURNED TO MMDG FOR INVESTIGATION, IT OPERATED AS EXPECTED. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. BASED ON THE INFORMATION PROVIDED TO MMDG AND THE INVESTIGATION, THE PUMP APPEARS TO HAVE PERFORMED AS EXPECTED. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE PATIENTS DEATH.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATES THAT THE PATIENT PASSED AWAY DURING THE NIGHT. THEY STATED THAT THE PATIENT USED THE PUMP AT NIGHT FOR FEEDINGS AT A RATE OF 55 ML/HR AND A CONTINUOUS DOSE. THEY SUSPECTED THAT THE PATIENT HAD ASPIRATED AND DIED. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER, BUT THEY DID NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE EVENT OR THE PATIENTS OFFICIAL CAUSE OF DEATH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2936372 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL INFUSION PUMP LZH MOOG MEDICAL DEVICES GROUP INFKIT2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Death