BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 19838497 · Received July 26, 2024

    Report

    Report Number
    3012307300-2024-06687
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    March 6, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150292
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED FOR ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE CUSTOMER'S REPORTED EVENT WAS VERIFIED DURING FUNCTIONAL TESTING. THE PROBABLE CAUSE IS THE PRINTER WIRE ASSEMBLY BOARD.

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE: +1(800)947-1277 EXT 6654. H3, H6: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALERTED ERROR CODE 41786. THE PRODUCT FAULT OCCURRED ON START-UP, AND IT WAS A NEW PUMP FAILURE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914116 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown