BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRICIA, FLOCAR

    MDR report key: 2048143 · Received April 4, 2011

    Report

    Report Number
    1722139-2011-00048
    Event Type
    Injury
    Date Received
    April 4, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING (B)(4) WAS SUBMITTED TO THE (B)(6) GOVERNMENT, (B)(6) IN RESPONSE TO THE INCIDENT. THE PUMP HAS NOT BEEN RETURNED TO THE MMDG FOR EVALUATION. NUTRICIA (MMDG CUSTOMER) HAS BEEN COMMUNICATING WITH THEIR CUSTOMER IN AN ATTEMPT TO RETRIEVE THE PUMP FOR FURTHER INVESTIGATION. MMDG HAS OPENED A CORRECTIVE AND PREVENTIVE ACTION PROJECT TO DETERMINE ROOT CAUSE FOR THIS ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED AS NEW INFORMATION IS OBTAINED. THIS DEVICE IS SOLD EXCLUSIVELY TO AN INTERNATIONAL MARKET. THE PUMP IS MANUFACTURED TO SPECIFICATION BY MMDG FOR NUTRICIA. 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

    HOME CARE MEDICAL FEEDING TREATMENT. PUMP IS STRAPPED TO PATIENT'S (CHILD) BACK. DELIVERY SETTINGS WERE 45 ML/HR, 180ML DOSE. PARENT RESPONDED TO AN OCCLUSION ALARM BY STOPPING PUMP. WITHOUT REMOVING OCCLUSION (KINK IN GIVING SET WHILE PATIENT RESTING ON LINE), THE PUMP WAS PLACED INTO PRIME MODE. (FILL SET BUTTON PRESSED). AFTER PRIME COMPLETED (APPROXIMATELY 40 SECONDS) THE PUMP WAS RE-STARTED. (PRESS START STOP BUTTON). NO FURTHER ALARM OCCURRED, PUMP DISPLAYED NORMAL INFUSION, THE VOLUME DELIVERED RATE INCREASING NORMALLY. NO ACTUAL INFUSION OCCURRED AND PARENT WAS NOT AWARE PUMP WAS STILL IN OCCLUDED STATE. FURTHER TESTS SHOW THIS SITUATION IS REPEATABLE. TURN ON PUMP, OCCLUDE DISTAL END, PRIME PUMP, OPERATOR FAIL TO OBSERVE AND/OR IGNORE OCCLUSION, START INFUSION -PUMP WILL INDICATE NORMAL INFUSION IN PROGRESS EVEN THOUGH FULLY OCCLUDED. FAILURE TO DELIVER PRESCRIBED FEEDING DOSE TO PATIENT PROVOKED A HYPOGLYCEMIC REACTION. (KNOWN MEDICAL CONDITION IF FEEDING REGIME NOT ADHERED TO.) PARENTS WERE ABLE TO TREAT SYMPTOMS AND NO FURTHER ADVERSE REACTIONS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention