BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRICIA FLOCARE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 6189244 · Received December 20, 2016

    Report

    Report Number
    1722139-2016-00620
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED AND EVALUATED FOR THE COMPLAINT. DURING THE INVESTIGATION IT WAS CONFIRMED THAT THE PUMP DID NOT DELIVER. THE PUMP WAS REPAIRED AND RETURNED. THIS REPORT WAS FILED BECAUSE THE PUMP INVOLVED IN THE COMPLAINT IS SIMILAR TO THE INFINITY PUMP MARKETED IN THE US.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT PUMP CONTINUED TO RUN AND DISPLAYED 200ML WAS DELIVERED, THOUGH ACTUALLY NO FEED WAS DELIVERED AND THAT THE PUMP DID NOT ALARM. THE PATIENT SUFFERED A SUSPECTED HYPOGLYCAEMIC ATTACK WHILST BEING CONTINUOUSLY FED WITH NUTRINI AT 20ML/H. BLOOD SUGAR LEVEL (BSL) TAKEN 1.9. THE PATIENTS PARENTS GAVE APPLE JUICE WHICH BROUGHT UP BSL TO 5 WITHIN 30 MINUTES AND THUS FORTUNATELY THE BOY RECOVERED QUITE WELL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839078 NUTRICIA FLOCARE INFINITY ENTERAL FEEDING PUMP INFUSION PUMP, ENTERAL LZH MOOG MEDICAL DEVICES GROUP 26514-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention