BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY ONE AMBULATORY INFUSION PUMP

    MDR report key: 20658083 · Received November 11, 2024

    Report

    Report Number
    3012307300-2024-13100
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 11, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. ONE DEVICE WAS RECEIVED FOR EVALUATION. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. VISUAL TESTS FOUND A DAMAGED REAR HOUSING AND DAMAGED AC CONNECTOR. THE FUNCTIONAL TEST FOUND A DEFECTIVE DOWNSTREAM OCCLUSION (DSO) SENSOR, DEFECTIVE CAPACITOR, AND AN OLD MOTOR (MORE THAN 2 MILLION REVOLUTIONS- 4140329). THE ROOT CAUSE OF THE ISSUE WAS A DAMAGED AC CONNECTOR. THE AC CONNECTOR WILL BE REPLACED TO SOLVE THE ISSUE. THE DSO SENSOR, CAPACITOR AND MOTOR WILL ALSO BE REPLACED.

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED PRODUCT FOR A BROKEN INTERNAL POWER CONNECTOR, DURING PHYSICAL INSPECTION IT WAS FOUND A DEFECTIVE DOWNSTREAM OCCLUSION (DSO) SENSOR, DEFECTIVE CAPACITOR, AND AN OLD MOTOR (MORE THAN 2 MILLION REVOLUTIONS- 4140329). THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976996 CADD-LEGACY ONE AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown