BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 20921081 · Received December 12, 2024

    Report

    Report Number
    1722139-2024-00683
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 14, 2024
    Report Date
    November 14, 2024
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    UDI-DI
    10814844000075
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO MMD FOR EVALUATION. A DHR REVIEW WAS COMPLETED AND NO NON-CONFORMANCES WERE FOUND. BECAUSE THE DEVICE WAS NOT RETURNED TO MMD FOR EVALUATION, AN INVESTIGATION COULD NOT BE COMPLETED. THIS REPORT WILL BE UPDATED IF THE DEVICE IS RETURNED TO MMDG.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO MMD FOR EVALUATION. A DHR REVIEW WAS COMPLETED AND NO NON-CONFORMANCES WERE FOUND. WHEN THE DEVICE WAS RETURNED TO MMD FOR INVESTIGATION, IT OPERATED AS EXPECTED. MMD COULD NOT REPLICATE OR CONFIRM THE REPORTED COMPLAINT. BASED ON THIS INFORMATION NO MDR WOULD HAVE BEEN REQUIRED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THAT THE PUMP UNDER INFUSED AT A RATE THE MMD WOULD CONSIDER REPORTABLE. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, WHO STATED THAT THE COMPLAINT OCCURRED DURING TESTING AND HAD NOT HAD ANY EFFECT ON A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THAT THE PUMP UNDER INFUSED AT A RATE THE MMD WOULD CONSIDER REPORTABLE. MMD DID FOLLOW UP WITH THE INITIAL REPORTER, WHO STATED THAT THE COMPLAINT OCCURRED DURING TESTING AND HAD NOT HAD ANY EFFECT ON A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. [COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905400 ENTERALITE INFINITY ENTERAL FEEDING PUMP ENTERAL INFUSION PUMP LZH MOOG MEDICAL DEVICES GROUP INFKIT2 N/A 10814844000075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown