BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ADMINISTRATION SET

    MDR report key: 13052555 · Received December 21, 2021

    Report

    Report Number
    1722139-2021-00962
    Event Type
    Death
    Date Received
    December 21, 2021
    Date of Event
    November 29, 2021
    Report Date
    November 29, 2021
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    PIO
    PMA / PMN Number
    K142539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO MMDG FOR EVALUATION. A DHR COULD NOT BE COMPLETED BECAUSE NO LOT NUMBER WAS PROVIDED. BECAUSE THE DEVICE WAS NOT RETURNED, MMDG HAS BEEN UNABLE TO INVESTIGATE THE COMPLAINT. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. BASED ON THE INFORMATION PROVIDED TO MMDG THE PUMP AND ADMINISTRATION SET APPEAR TO HAVE BEEN PERFORMING 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 WAS TANGLED IN THE TUBING AND WAS STRANGLED. THEY ADVISED THAT THEY HAD CONNECTED THE ADMINISTRATION SET TO THE PATIENTS FEEDING TUBE AND THEN "DOZED OFF" WITH THE FEEDING RUNNING. THEY STATED THAT THEY WOKE UP WHEN THE HEARD THE PATIENT MOVING AROUND AND WHEN THEY WENT TO CHECK ON THE PATIENT, THE TUBING HAD WRAPPED AROUND HIS NECK. THEY STATED THAT THEY ATTEMPTED RESUSCITATION, BUT THE PATIENT PASSED AWAY AT HOME. THE INITIAL REPORTER WAS UNSURE IF THE PATIENT WAS TAKEN TO THE HOSPITAL. MMDG DID FOLLOW UP WITH THE INITIAL REPORTER, BUT THEY DID NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE EVENT, AND ASKED NOT TO BE CONTACTED AGAIN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954367 ENTERALITE INFINITY ADMINISTRATION SET ENTERAL FEEDING SET PIO MOOG MEDICAL DEVICES GROUP NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Male Death