BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOCARE INFINITY - WESTERN EUROPE

    MDR report key: 2031004 · Received March 16, 2011

    Report

    Report Number
    1722139-2011-00038
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 18, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING (B)(4) WAS SUBMITTED IN RESPONSE TO THE INCIDENT DESCRIBED IN THIS MDR. THE PUMP IS MANUFACTURED TO SPECIFICATION BY (B)(4) FOR THE (B)(4) MFR. 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 UNITED STATES. PUMP WAS NOT RETURNED TO UNITED STATES. MFR'S ANALYSIS: ON ARRIVAL, THE PUMP HAS BEEN INVESTIGATED. THE OCCLUSION ALARM FUNCTION OF THE PUMP WAS TESTED AND FOUND TO BE WORKING AS EXPECTED GIVING AN OCCLUSION ALARM IN CASE UPSTREAM AND DOWN STREAM OCCLUSIONS WERE SIMULATED. ON READING THE PUMP LOG HISTORY FILE, IT SHOWS AN OCCLUSION ALARM PRECEDING THE ACTUAL EVENT. FROM THE LOG FILE, WE COULD ALSO READ THAT THE PRIME FUNCTION WAS USED DIRECTLY FOLLOWING THIS OCCLUSION EVENT. USING THE PRIME FUNCTION WHILE THERE STILL IS AN OCCLUSION IS AGAINST THE INSTRUCTIONS FOR USE AS THIS WILL RE-CALIBRATE THE OCCLUSION ALARM PARAMETERS OF THE PUMP. THE PUMP IS SUBJECT OF FURTHER TESTS. THE USER QUITE LIKELY TRIED TO OVERCOME THE OCCLUSION SITUATION BY USING THE PRIME FUNCTION AND DID NOT RESOLVE THE OCCLUSION AS MENTIONED IN THE PRODUCT IFUS. INITIAL CORRECTIVE ACTIONS/PREVENTIVE ACTIONS: IMPLEMENTED BY THE MFR. REVISION OF THE IFU, ELABORATING IN MORE DETAIL ABOUT THE IMPORTANCE OF SOLVING THE OCCLUSION PRIOR TO CONTINUATION OF THE FEEDING REGIME OR CARRYING OUT ANY OTHER ACTIONS. THE PUMP PERFORMED AND FUNCTIONED AS INTENDED AND DESIGN.

    Description of Event or Problem · 1

    PT (B)(6) OF AGE WITH GLYCOGEN STORAGE DISEASE TYPE BI. DURING OVERNIGHT FEEDING, THE PUMP STOPPED W/O ALARMING. NEXT MORNING, CHILD WAS FOUND BY PARENT WITH A BLOOD SUGAR LEVEL OF 0.5 MMOL/K. FATHER (MEDICAL DOCTOR) ADMINISTERED GLUCOSE. PATIENT INJURY/MEDICAL INTERVENTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOCARE INFINITY - WESTERN EUROPE LZH MOOG MEDICAL DEVICES GROUP 35676

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR