BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCARE INFINITY 1 PUMP

    MDR report key: 2251598 · Received August 30, 2011

    Report

    Report Number
    1722139-2011-00279
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    February 11, 2010
    Report Date
    April 15, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FEEDING SET WAS RETURNED WITH THE PUMP. INVESTIGATION SHOWED A THICK COATING OF FOOD ON THE INSIDE WALL OF THE TUBING AND PRISM. THE PUMP WAS TESTED WITH THE RETURNED SET AND DID NOT ALARM AIR. THE COMPLAINT WAS CONFIRMED. THE PUMP PERFORMED ACCORDING TO SPECIFICATIONS WHEN TESTED WITH A NEW, KNOWN GOOD SET. THE PUMP WAS CALIBRATED AND RETURNED TO THE CUSTOMER. THIS MDR IS BEING FILED AS PART OF THE RETROSPECTIVE REVIEW FOR REPORTABILITY.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE PUMP CONTINUED TO RUN AFTER THE SET WAS EMPTY AND DID NOT ALARM AIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability