BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE CADD MS3

    MDR report key: 21105512 · Received January 7, 2025

    Report

    Report Number
    MW5164411
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Report Date
    January 2, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOSE OR AMOUNT: USE WITH REMODULIN MDV, DOSE 10MG/ML; 1-150 NG PER KG PER MIN. PATIENT REPORTED THAT THE MS-3 "PLASTIC" PIECE THAT THE CARTRIDGE CPAP SCREWS ONTO IS BROKEN, AND THE CARTRIDGE CANNOT BE SCREWED ON SECURELY. DATE OF DEVICE FAILURE IS UNKNOWN. PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT. THE DEVICE IS AVAILABLE FOR RETURN. PATIENT HAD A BACK-UP PRODUCT TO USE AND WAS ABLE TO CONTINUE THERAPY. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323491 CARTRIDGE CADD MS3 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 21-7450-24

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ADEMPAS| LIDOCAINE / PRILOCAINE CRM | REMODULIN MDV