BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS3 PUMP

    MDR report key: 18368045 · Received December 20, 2023

    Report

    Report Number
    3012307300-2023-12144
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 1, 2023
    Report Date
    February 19, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE MOST PROBABLE CAUSE FOR THE PUMP NOT TURNING ON IS DUE TO THE BATTERY NOT BEING INSERTED IN THE CORRECT ORIENTATION (THE PLUS SIDE GOES IN FIRST); HOWEVER, THIS CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE SERVICE HISTORY REVIEW IDENTIFIED NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. B3 UNKNOWN, H3: DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP DID NOT INFUSE FOR 24 HOURS. THE ALARM DID NOT TURN ON. FOLLOWING A PUMP RESTART, THE PATIENT EXPERIENCED HEADACHE AND GASTROINTESTINAL UPSET. DOSE WAS AT 91.4 NKM AND RESTARTED REMODULIN AT 46 NKM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153828 CADD MS3 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 7400 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female CADD CASSETTE| REMODULIN