BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERNATIONAL INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2132748 · Received June 10, 2011

    Report

    Report Number
    1722139-2011-00086
    Event Type
    Other
    Date Received
    June 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO RECEIVED FROM THE HEALTH CARE PROVIDER THE PUMP COULD HAVE BEEN FUNCTIONING PROPERLY. THE PRESENCE OF A KINK IN THE TUBING SET IS NOT ALWAYS AN INDICATION THE LINE IS OCCLUDED. IN THIS CASE, THE LINE COULD HAVE BEEN PARTIALLY OPENED ALLOWING FORMULA TO CONTINUE TO THE PT. THE PUMP OCCLUSION ALARM WOULD NOT HAVE BEEN TRIGGERED. A F/U REPORT WILL BE SUBMITTED ONCE THE PUMP IS RECEIVED AND EVALUATED OR ADDITIONAL PT INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED; CHILD HAD A SEIZURE IN THE MIDDLE OF THE NIGHT, WHEN THEY CHECKED, FOUND THAT THE TUBING WAS CLAMPED ON THE PT SIDE AND NO ALARMS HAD OCCURRED. PT INJURY OR MEDICAL INTERVENTION: NO. A F/U CALL TO THE HEALTH CARE PROVIDER RESULTED IN THE FOLLOWING ADDITIONAL USER INFO: THE PT HAD A SEIZURE AND WHEN PARENTS RAN IN, NOTICED THAT THE PT WAS LYING ON THE TUBING AND THE PUMP HAD NOT TRIGGERED AN OCCLUSION ALARM. THE PARENTS NOTICED THE TUBING WAS KINKED AND CORRECTED IT. THE HEALTH CARE PROVIDER REPORTED THE SEIZURE WAS UNRELATED TO FEEDING OR LACK THEREOF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR