BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ORANGE PUMP

    MDR report key: 2061314 · Received April 8, 2011

    Report

    Report Number
    1722139-2011-00054
    Event Type
    Other
    Date Received
    April 8, 2011
    Report Date
    April 8, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DOES NOT WISH TO RETURN THE DEVICE TO (B)(6) FOR FURTHER EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED TO DETERMINE IF THERE WERE ANY NON CONFORMANCES OR IRREGULARITIES THAT COULD HAVE CONTRIBUTED TO THIS TYPE OF MALFUNCTION. THE DHR DID NOT CONTAIN ANY NON CONFORMANCES. A REVIEW OF THE COMPLAINT TREND FOR THIS TYPE OF FAILURE MODE WAS COMPLETED. NO ADVERSE TRENDS WERE IDENTIFIED. SHOULD NEW INFO BECOME AVAILABLE, OR THE PUMP RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: SHE IS USING THE INFINITY ORANGE FOR BREAST MILK FORTIFIED WITH (B)(6). WHEN SHE SETS THE PUMP TO "HUMAN MILK" AND SETS A DOSE, IT SEEMS TO WORK FINE MOST OF THE TIME. THERE ARE SOME OCCASIONS WHERE SHE HAS TO USE FORMULA INSTEAD OF BREAST MILK. WHEN SHE DOES THIS AND SETS THE PUMP TO "FORMULA", THE PUMP DOES NOT OFTEN SENSE WHEN THE BAG IS EMPTY AND IT WILL END UP PUMPING AIR INTO THE PT'S NG TUBE. THIS SOMETIMES HAPPENS WITH THE OVERNIGHT FEEDS IF SHE IS NOT WATCHING IT CLOSELY AND IT HAPPENS MORE OFTEN WHEN IT IS HUNG ON THE IV POLE RATHER THAN HANGING IT SOMEWHERE ELSE. (SHE HAS BEEN PROPPING IT ON THE COUCH AND SAYS IT TENDS TO WORK BETTER THIS WAY). PT INJURY OR MEDICAL INTERVENTION: NO INJURY REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK