BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY FLOCARE PUMP

    MDR report key: 2038709 · Received March 24, 2011

    Report

    Report Number
    1722139-2011-00045
    Event Type
    Other
    Date Received
    March 24, 2011
    Report Date
    March 23, 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

    THE EVALUATION INCLUDED PERFORMANCE TESTING (ACCURACY, VERIFICATION OF AIR/NO FOOD ALARM, ETC.). MULTIPLE FORMULAS AND SETTINGS WERE USED 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. NOTE: THE FLOCARE PUMP IS MANUFACTURED TO SPECIFICATION BY MMDG FOR THE (B)(4). THIS DEVICE IS SOLD EXCLUSIVELY TO AN INTERNATIONAL MARKET. HOWEVER, IT IS SIMILAR TO THE ENTERALITE INFINITY ENTERAL FEEDING PUMP AVAILABLE FOR DISTRIBUTION IN THE U.S. PUMP WAS NOT RETURNED TO US.

    Description of Event or Problem · 1

    CUSTOMER STATES, PUMP DID NOT STOP WHEN FEED WAS FINISHED, CONTINUING TO PUMP AIR INTO PATIENT. PT INJURY/MEDICAL INTERVENTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY FLOCARE PUMP LZH (SIMILAR DEVICE) LZH MOOG MEDICAL DEVICES GROUP FLOCARE PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK