BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY

    MDR report key: 8645964 · Received May 24, 2019

    Report

    Report Number
    MW5086921
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 16, 2019
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMAIL FROM (B)(6) "S CNSS" STATING GOT A CALL FROM CARE FACILITY. PUMP HAS LOST PROGRAMMING. PATIENT IS USING BACK UP PUMP. SN FOR PUMP IN QUESTION (B)(4). REPLACEMENT BEING SENT. NO FURTHER INFORMATION. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? NO. IS THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT CLINICAL INJURY? NO. IS THE ACTUAL DEVICE TO BE RETURNED FOR INVESTIGATION? YES. DID WE REPLACE THE DEVICE? YES. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436198 CADD LEGACY LEGACY INFUSION PUMP FRN SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO