BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1669092 · Received April 23, 2010

    Report

    Report Number
    1722139-2010-00052
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 22, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    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 SPEC DURING EACH RUN (ALARMED AND SHUT OFF AFTER FOOD WAS GONE). CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. THE PUMP PERFORMED ACCORDING TO SPEC. THE DISPOSABLE SET USED AT THE TIME OF THE FAILURE WAS NOT RETURNED WITH THE PUMP AND COULD NOT BE EVALUATED. WE ARE ATTEMPTING TO CONTACT THE CUSTOMER/PT TO OBTAIN MORE INFO. IF MORE CUSTOMER/PT INFO BECOMES AVAILABLE, A FOLLOW UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: PUMP CONTINUED TO PUMP AFTER FORMULA WAS GONE. CUSTOMER STATED "PUMP CONTINUED TO RUN AFTER FORMULA WAS GONE. BIOMED DID TEST PUMP AND FOUND IT TO RUN FINE BUT DID FIND THAT THE FORMULA DID LEAVE A FILM POSSIBLY CAUSING THE CONTINUED RUN." PT INJURY? NO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1