BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORANGE INFINITY EFP W/ ADAPTER AND CLAMP

    MDR report key: 4264641 · Received October 28, 2014

    Report

    Report Number
    1722139-2014-00150
    Event Type
    Injury
    Date Received
    October 28, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP'S ACCURACY, ALARMS, AND SENSORS WERE ALL TESTED AND FOUND TO BE WORKING PROPERLY. THE COMPLAINT COULD NOT BE VERIFIED.

    Description of Event or Problem · 1

    CUSTOMER STATES: FOOD PUMP DID NOT DELIVER FORMULA OR ALARM. THE BABY BECAME HYPOGLYCEMIC AS A RESULT OF NO FEEDINGS FOR 7 HOURS. MOM SAID SHE FILLED THE BAG AT 3 AM AND ONLY PUTS IN ABOUT 4 HOURS OF FORMULA AT A TIME. WHEN SHE WOKE UP IN THE MORNING AT 10, THE BAG WAS STILL FULL. SHE SAID THAT SHE COULD SEE FORMULA MOVING BACK AND FORTH IN THE TUBING, BUT IT WASN'T FLOWING THOUGH. THEY USE NEOCATE FORMULA, WIPE THE FOOD PUMP WITH A BABY WIPE WHEN IT'S DIRTY TO CLEAN IT. THE PUMP IS SET AT A RATE OF 38 ML/HR FOR CONTINUOUS FEEDS, SHE SAID THEY USUALLY SET THE DOSE AT 330 AS A BACK UP BECAUSE THE PUMP HAS CONTINUED TO PUMP AIR BEFORE WHEN THE BAG IS EMPTY. THE TOTAL VOLUME DELIVERED, ACCORDING TO THE PUMP SAID 280. FOOD PUMP WAS EXCHANGED OUT OF THE HOME. RE-EDUCATION WITH MOM WAS DONE ON PROPER CLEANING OF THE FOOD PUMP, PROPERLY SETTING THE DOSE SO THAT IT ALARMS APPROPRIATELY, AND MIXING FORMULA ACCORDING TO MANUFACTURER RECOMMENDATIONS. MOM STATED THAT THEY HAD TO DO INTERVENTIONS THROUGHOUT THE DAY DUE TO HER BEING HYPOGLYCEMIC AND THEN BECOMING HYPERGLYCEMIC AFTER THE INTERVENTION. SHE STATED PATIENT WAS SICK ALL DAY, BUT DID NOT REQUIRE HOSPITALIZATION OR A DOCTOR VISIT. UPON F/U , THE CLINICIAN INVOLVED REPORTED THE ADDITIONAL EDUCATION WAS PROVIDED TO THE MOTHER BECAUSE THE MOTHER STATES SHE DIDN'T SET THE SPECIFIC DOSE FOR THE AMOUNT IN THE BAG BECAUSE SHE ONLY USED THE "NO FOOD" ALARM TO INDICATE THE FEEDING BAG WAS EMPTY AND THEN SHE WOULD FILL THE BAG UP AGAIN WITH ENOUGH FOOD FOR ANOTHER 4 HOUR FEEDING. ALSO CLAIMS THERE IS NOT A RECORD OF DIABETES IN THE PATIENT SO SHE SUSPECTS THE MOTHER DOESN'T HAVE THE TOOLS TO TEST FOR BLOOD SUGAR LEVELS AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688019 ORANGE INFINITY EFP W/ ADAPTER AND CLAMP INFUSION PUMP, ENTERAL, EXTERNAL LZH MOOG MEDICAL DEVICES GROUP INFORNG

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other NEOCATE