BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION

    MDR report key: 13361355 · Received January 26, 2022

    Report

    Report Number
    3012307300-2022-01812
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Report Date
    March 31, 2022
    Manufacturer
    NULL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE MEDFUSION PUMP WAS RETURNED FOR INVESTIGATION IN USED CONDITION. THERE WAS MOTOR RATE ERROR IN THE EVENT HISTORY LOG (EHL). AN OCCLUSION TEST WAS PERFORMED. THE MOTOR RATE ERROR WAS REPRODUCED DURING FUNCTIONAL TESTING. THE ISSUE WAS OCCURRING BECAUSE THE INVOLVED COMPONENTS WERE WORN. THE MOTOR ASSEMBLY (STEPPER MOTOR INCLUDED), WORM GEAR, LEADSCREW AND CLUTCH HALVES WAS REPLACED TO ADDRESS THE REPORTED PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PRODUCT CODE WAS PROVIDED.

    Description of Event or Problem · 0

    ORACLE RO : 1170586 MOTOR RATE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499618 PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown