BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERALITE INFINITY ENTERAL PUMP DELIVERY SET 500ML

    MDR report key: 13600243 · Received February 24, 2022

    Report

    Report Number
    MW5107701
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    February 19, 2022
    Report Date
    February 22, 2022
    Manufacturer
    MOOG / ZEVEX, INC.
    Product Code
    PIF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OUR (B)(6) OLD SON HAS A GASTROSTOMY TUBE FOR RECEIVING ALL OF HIS FEEDINGS FOR NUTRITION. HIS FEEDINGS ARE DONE WITH A MOOG ENTERALITE INFINITY ENTERAL PUMP DELIVERY SET (INF0500-A). HIS CURRENT FEEDING SCHEDULE INCLUDES AN OVERNIGHT CONTINUOUS FEEDING FROM 22:00 TO 07:00 AT 45 ML/HR. ON (B)(6) 2022 IN THE EARLY MORNING (AROUND 04:00), WE WOKE UP TO OUR SON CRYING. THE ENTERAL FEEDING SET WAS WRAPPED COMPLETELY AROUND HIS NECK. WE IMMEDIATELY UNWRAPPED THE ENTERAL FEEDING SET FROM HIS NECK. HE WAS NOT INJURED; HOWEVER, WE FEAR THAT IF HE HAD NOT WOKEN US UP BY CRYING THAT HE COULD HAVE STRANGLED HIMSELF IN THE FEEDING SET LEADING TO POSSIBLE DEATH. WE HAVE CONTACTED OUR SON'S GI DOCTOR AND ARE AWAITING INSTRUCTIONS ON HOW WE CAN MITIGATE THE RISKS ASSOCIATED WITH OVERNIGHT CONTINUOUS FEEDINGS WHEN WE ARE ASLEEP AND CANNOT ACTIVELY MONITOR WHETHER OR NOT HE IS TANGLED IN THE ENTERAL FEEDING SET. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760828 ENTERALITE INFINITY ENTERAL PUMP DELIVERY SET 500ML GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Male Required Intervention AMT MINI-ONE G-TUBE 14FR 1.2CM| AZITHROMYCIN ORAL SUSPENSION| OMEPRAZOLE ORAL SUSPENSION