BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 21085802 · Received January 6, 2025

    Report

    Report Number
    3012307300-2025-00310
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 9, 2024
    Report Date
    April 3, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D3. MANUFACTURING PLANT ADDRESS, CITY, ZIP CODE, STATE, COUNTRY: CORRECTED. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALARMED WITH DOWNSTREAM CONCLUSION MESSAGE DISPLAYED ON THE SCREEN. THE PUMP WAS CONNECTED TO A PATIENT WHEN THE ERROR/EVENT OCCURRED. CONTINUOUS INFUSION RATE:2.2 ML/HR. TOTAL RESERVOIR VOLUME: 101. GIVEN: 5 ML. LOCK LEVEL: LOCKED. A CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) WAS USED TO FILL CASSETTE. THE PUMP WAS NOT USED TO PRIME THE EXTENSION TUBING. CADD SOLIS PUMP SKU NUMBER FOR ITEMS WERE USED DURING THIS INFUSION (ADMIN SET, CASSETTE ETC.) CADD EXTENSION SET REFERENCE NUMBER: (B)(4), CASSETTE REFERENCE NUMBER (B)(4). LOT NUMBERS FOR EACH ITEM USED (ADMIN SET, CASSETTE ETC.): CASSETTE LOT 6022044, CADD EXTENSION LOT 6022120. THE PATIENT WAS NOT MEDICALLY AFFECTED AND THERE WAS A DELAY IN MEDICATION. ADDITIONALLY, THE PUMP ADMINISTERED ONLY 5 ML AND THEREFORE DID NOT DELIVER FULL MEDICATION. IT WAS SEQUESTERED FOR INVESTIGATION. THE CASSETTE CONTAINING REMAINDER OF MEDICATION WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351557 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP,INFUSION FRN SMITHS MEDICAL ASD, INC 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown A CLOSED SYSTEM DRUG TRANSFER DEVICE.