BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERNATIONAL INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2120460 · Received May 25, 2011

    Report

    Report Number
    1722139-2011-00087
    Event Type
    Other
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE WAS EVALUATED. RESULTS: THE EVAL INCLUDED PERFORMANCE TESTING (ACCURACY, VERIFICATION OF AIR/NO FOOD ALARM, ETC.). MULTIPLE FORMULAS AND SETTINGS WERE USED TO RECREATE THE FAILURE EXPERIENCED BY THE CUSTOMER. THE PUMP PERFORMED ACCORDING TO SPECIFICATION DURING EACH RUN (ALARMED AND SHUT OFF PER THE INSTRUCTIONS IN THE USER MANUAL). THE SET USED WITH THE PUMP AT THE TIME THE EVENT OCCURRED COULD HAVE CONTRIBUTED TO THE FAILURE BUT WAS NOT RETURNED WITH THE PUMP. CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. THE PUMP PERFORMED ACCORDING TO SPECIFICATION. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD NEW OR ADD'L PT INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED; END USER STATED THERE WAS A NO FLOW ALARM AND THE PUMP RESET AND COMPLETED THE THERAPY. PATIENT INJURY OR MEDICAL INTERVENTION: YES, THE PATIENT DEVELOPED STOMACH PAINS. A FOLLOW UP CALL TO THE PROVIDER RESULTED IN THE FOLLOWING USER INFO. NURSE STATES; PUMP WAS HAVING "NO FLOW" ALARMS ON AND OFF ALL DAY. "NO FLOW" WAS NOT ABLE TO BE CLARIFIED. CUSTOMER (B)(4) WAS UNABLE TO FIND OUT IF IT WERE "NO FLOW IN/OUT" OR A "NO FOOD" ALARM. STATES PT HAD A TEMPORARY STOMACH ACHE. NO MEDICAL INTERVENTION NECESSARY. (B)(4) REP EVALUATED THE PUMP BUT COULD NOT DUPLICATE THE FAILURE.

    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 8 YR