BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUTRICIA FLOCARE INFINITY

    MDR report key: 2061042 · Received April 4, 2011

    Report

    Report Number
    1722139-2011-00046
    Event Type
    Other
    Date Received
    April 4, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE EVALUATION INCLUDED PERFORMANCE TESTING (ACCURACY, VERIFICATION OF AIR/NO FOOD ALARM, ETC.). MULTIPLE FORMULAS AND SETTINGS WERE USE TO RECREATE THE FAILURE EXPERIENCED BY THE CUSTOMER. THE PUMP PERFORMED ACCORDING TO SPECIFICATION DURING EACH RUN (ALARMED AND SHUT OFF AFTER FOOD WAS GONE). THE SET THAT WAS USED WITH THIS PUMP WHEN THE MALFUNCTION OCCURRED COULD HAVE CONTRIBUTED TO THIS MALFUNCTION BUT WAS NOT RETURNED FOR EVALUATION. CONCLUSION: THE PUMP PERFORMED ACCORDING TO SPECIFICATION. THIS DEVICE IS SOLD EXCLUSIVELY TO AN INTERNATIONAL MARKET. THE PUMP IS MANUFACTURED TO SPECIFICATION BY (B)(4). THE FLOCARE INFINITY PUMP IS SIMILAR TO THE ENTERALITE INFINITY ENTERAL FEEDING PUMP WHICH IS AVAILABLE FOR DISTRIBUTION IN THE UNITED STATES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THE PUMP WAS NOT ALARMING WHEN DONE AND CONTINUED TO PUMP AIR INTO THE PATIENT. PATIENT INJURY OR MEDICAL INTERVENTION? NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTRICIA FLOCARE INFINITY LZH MOOG MEDICAL DEVICES GROUP FLOCARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK