BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1349516 · Received December 22, 2008

    Report

    Report Number
    1722139-2008-00005
    Event Type
    Malfunction
    Date Received
    December 22, 2008
    Date of Event
    September 19, 2008
    Report Date
    December 16, 2008
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    1722139-12/03/08-0010-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE EVALUATED. RESULTS: DURING THE POWER ON PROCESS, THE PUMP TRANSFERS THERAPY/FEEDING DATA FROM THE EEPROM TO SOFTWARE MEMORY. THE THERAPY PARAMETERS IN THE MEMORY ARE BEING CORRUPTED. USING THESE CORRUPTED VALUES RESULTS IN ERRORS IN THE NORMAL OPERATION OF THE PUMP, FOR EXAMPLE, FEEDING AT A FASTER RATE THAN WAS PROGRAMMED. CONCLUSIONS: THE SOFTWARE PARAMETER CORRUPTION CAUSES THE PUMP TO OVERFEED. THE ROOT CAUSE FOR WHY THE PARAMETER CORRUPTION OCCURS IS UNKNOWN AT THIS TIME. THIS ERROR HAS NOT CAUSED PATIENT INJURY TO DATE. THIS MDR IS BEING COMPLETED AS PART OF THE FIELD CORRECTION. REFERENCE FIELD CORRECTION NUMBER ASSIGNED BY MOOG MEDICAL DEVICES GROUP.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS "WE HAVE A ZEVEX ENTERALITE INFINITY PUMP THAT HAS BEGUN TO INFUSE WITHOUT REGARD TO PROGRAMMED RATE. WHEN BEGINNING THE DOSE, THE DEVICE WILL SIMPLY RUN CONTINUOUSLY UNTIL THE ENTIRE PROGRAMMED DOSE IS DELIVERED. ALSO, A NORMALLY OPERATING ENTERALITE INFINITY HAS A MAXIMUM PROGRAMMABLE RATE OF 600 ML/HR. THESE 2 DEVICES CAN BE PROGRAMMED WITH A RATE OF UP TO 9999 ML/HR".

    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