BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOOG

    MDR report key: 2243957 · Received September 6, 2011

    Report

    Report Number
    MW5022156
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    September 5, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MOOG
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MOOG 1200ML ENTERALITE INFINITY PUMP DELIVERY SETS (2), USED ON (B)(6) 2011 SHOWED WITH CONSTANT NO FOOD, NO FLOW IN AND NO FLOW OUT ERRORS. I WOULD ADDRESS THE PUMP ERROR AND ANOTHER WOULD OCCUR. LOT NUMBER CF 1102113. THIS (B)(6) MALE HAS MITOCHONDRIAL DISEASE AND GI PROBLEMS; IS ON THE ENTERALITE INFINITY PUMP 24 HRS A DAY WITH PPN AND MEDICATIONS ADMINISTERED VIA THE PUMP. WE ARE AT THE POINT OF TRYING TO DETERMINE WHETHER THE CHILD WILL NEED IV NUTRITION. HOWEVER, DUE TO THE PUMP AND PUMP DELIVERY SET MALFUNCTIONS, HIS MEDICAL TEAM AND OUR FAMILY IS HAVING DIFFICULTY IN DETERMINING WHAT PROBLEMS ADMINISTERING THE NEEDED PUMP FLUIDS ARE DUE TO THE MALFUNCTIONING PUMP SETS AND WHAT ARE DUE TO GUT SHUT DOWN. IT WOULD BE WONDERFUL IF MOOG WOULD FIND A SOURCE OF THEIR OLD BAGS, WHICH SEEMED TO WORK BETTER, AS EACH BOX OF 30 HAS BETWEEN 5-10 WHICH MALFUNCTION (THESE ARE 1200 ML BAGS). ZEVEX ENTERALITE INFINITY PUMPS -2 USED- (B)(6) - BOTH HAD ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOOG ENTERALITE INFINITY 1200ML ENTERAL PUMP DELIVERY SET LZH MOOG INF 1200 CF1102113
    2 ZEVEX ENTERALITE INFINITY PUMP ENTERAL PUMP LZH ZEVEX
    3 ZEVEX ENTERALITE INFINITY PUMP ENTERAL PUMP LZH ZEVEX

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR