BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 20729537 · Received November 19, 2024

    Report

    Report Number
    1722139-2024-00635
    Event Type
    Death
    Date Received
    November 19, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 23, 2024
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    UDI-DI
    10814844000181
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO MMD FOR EVALUATION. A DHR REVIEW WAS COMPLETED AND DID NOT SHOW THE CURRENTLY REPORTED ISSUE. BECAUSE THE DEVICE WAS NOT RETURNED, MMD HAS BEEN UNABLE TO INVESTIGATE THE COMPLAINT. THIS REPORT WILL BE UPDATED WHEN THE PATIENTS AUTOPSY RESULTS ARE PROVIDED OR IF THE DEVICE IS RETURNED TO MMD.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATES THAT THE PATIENT HAD PASSED AWAY "FROM POSSIBLY BEING TANGLED IN TUBING". THE PATIENTS MOTHER REPORTED THAT THEY HAD PLACED THE BABY IN A SUPINE POSITION AND STARTED THEIR NIGHTTIME FEEDING. THEY STATED THAT THE PUMP AND BAG WERE MOUNTED ON AN IV POLE. THEY REPORTED THAT THEY STARTED THE FEEDING, EXITED THE ROOM AND CAME BACK 15 MINUTES LATER "CHECKING ON THE PATIENT AND ALL WAS WELL". THEY STATED THAT THEY REPEATED THIS, COMING BACK 15 MINUTES LATER TO CHECK ON THE PATIENT AGAIN AND THAT "THE BAG SET TUBING WAS WRAPPED AROUND THE PATIENTS ABDOMEN". SHE STATES AT THAT TIME SHE UNTANGLED THE TUBING AND RESTARTED THE FEEDING, RETURNING 20 MINUTES LATER, WHERE SHE REPORTS THAT THE TUBING WAS "WRAPPED ONCE AROUND HIS ABDOMEN AND ONCE AROUND HIS NECK AND THAT THE PATIENT WAS LIFELESS". THE INITIAL REPORTER STATED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE, AND THAT RESUSCITATION EFFORTS HAD BEEN SUCCESSFUL EN ROUTE. THE HOSPITAL REPORTED THAT WHEN THEY ASSESSED THE CHILD THEY FOUND "NO EMESIS OR SIGN OF STRUGGLE" AND NOTED ABRASIONS TO BOTH SIDES OF THE NECK. THEY REPORTED THAT AFTER A CT SCAN AND MRI CONFIRMED HYPOXIC INJURY AND CONTINUED EVOLUTION OF SAID INJURY, THAT LIFE SUPPORT WAS WITHDRAWN. FOLLOW UP INFORMATION RECEIVED BY MMD INDICATED THAT THE DEATH WAS BEING INVESTIGATED BY HOMICIDE DETECTIVES, BECAUSE ALL CHILD FATALITIES ARE "REGARDLESS OF WHETHER IT APPEARS TO BE CRIMINAL IN NATURE". THEY STATED THAT NO FURTHER ACTION WOULD BE TAKEN UNTIL THEY HAVE RECEIVED COMPLETED AUTOPSY RESULTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938641 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFP01 N/A 10814844000181

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male Death