BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP,FEEDING,ENTERAL,ENTRAFLO RNTL

    MDR report key: 19709820 · Received July 10, 2024

    Report

    Report Number
    1417592-2024-00721
    Event Type
    Death
    Date Received
    July 10, 2024
    Date of Event
    June 9, 2024
    Report Date
    September 18, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    LZH
    UDI-DI
    10888277420014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024, "THE PATIENT WAS SUPPOSED TO GET 400ML IN 2 HRS FROM THE ENTRAFLO FEEDING PUMP. THE MACHINE WAS BEEPING AND THE NURSE RESPONDED TO THE ALARM. THE RESIDENT WAS CHECKED AT 7:50AM AND IT WAS NOTICED 1200CC WAS DELIVERED. THE BAG THAT WAS HUNG WAS 1.5L, ONLY 300ML LEFT WHEN CHECKED BY NURSE. THE RESIDENT RECEIVED 1200ML IN 90 MIN. THE NURSE NOTICED THAT THE TUBING WAS NOT LOADED INTO THE PUMP CORRECTLY AND WAS FREE FLOWING. AS A RESULT, PARAMEDICS WERE DISPATCHED TO THE FACILITY. AN ATTEMPT WAS MADE TO GET THE RESIDENT TO THE HOSPITAL BUT SHE SUCCUMBED TO THE INCIDENT WHILE UNDER THE CARE OF PARAMEDICS. THE PATIENT IS DECEASED". THE DEVICE IS AVAILABLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE PUMP INVOLVED IN THE REPORTED INCIDENT (ENTR99235) WAS RETURNED BY THE FACILITY FOR OUR EVALUATION. USING KNOWN VARIABLES FROM THE COMPLAINT, 7 TRIALS WERE CONDUCTED RECREATING THE COMPLAINT TO THEORIZE HOW THE EVENT MAY HAVE OCCURRED.THE DOCUMENTED COMPLAINT INTERVIEW REPORTED THAT APPROXIMATELY 1200 ML WAS DELIVERED IN 90 MINUTES. IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED TO DELIVER 400 ML IN TWO HOURS AT A RATE OF 200 ML/HR. UNDER THESE CONDITIONS, THE PUMP WOULD NORMALLY DELIVER 300 ML. EVEN WITH THE MAX INFUSION RATE OF 295 ML/HR, MATHEMATICALLY ONLY 442.5 ML COULD BE DELIVERED WITHIN A 90 MINUTE WINDOW. INFORMATION PROVIDED FROM OUR INVESTIGATION AND INTERVIEWS FROM THE FACILITY WHERE THE EVENT TOOK PLACE CONCLUDE THAT THE REPORTED EVENT WAS NOT CAUSED BY A PRODUCT DEFICIENCY AND THAT THE EVENT COULD NOT HAVE OCCURRED WITHOUT THERE BEING SOME FORM OF FREE FLOW DURING AN INFUSION. THIS WOULD INDICATE THAT THE SET WAS LIKELY NOT SETUP CORRECTLY FOR THE INFUSION AS PROPER SETUP OF THE FEEDING SET WOULD INHIBIT FREE FLOW FROM OCCURRING. BASED ON THE INFORMATION AT HAND, THE COMPLAINT COULD NOT BE CONFIRMED TO BE A RESULT OF A QUALITY ISSUE WITH THE MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024, "THE PATIENT WAS SUPPOSED TO GET 400ML IN 2 HRS FROM THE ENTRAFLO FEEDING PUMP. THE MACHINE WAS BEEPING AND THE NURSE RESPONDED TO THE ALARM. THE RESIDENT WAS CHECKED AT 7:50AM AND IT WAS NOTICED 1200CC WAS DELIVERED. THE BAG THAT WAS HUNG WAS 1.5L, ONLY 300ML LEFT WHEN CHECKED BY NURSE. THE RESIDENT RECEIVED 1200ML IN 90 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446450 PUMP,FEEDING,ENTERAL,ENTRAFLO RNTL LZH MEDLINE INDUSTRIES LP 927324 10888277420014

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Death