BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 19887978 · Received August 1, 2024

    Report

    Report Number
    3012307300-2024-07039
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 12, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2) DEVICE EVALUATION: ANNEX A CODE UPDATED FROM A140302 TO A140504. H3, H6: THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER VISUAL INSPECTION AND FUNCTIONAL TESTING, THE CUSTOMER PROBLEM WAS NOT DUPLICATED. THE PUMP WAS FOUND TO BE SLIGHTLY OVER DELIVERING TO THE MANUFACTURING SPECIFICATIONS. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE MANUFACTURER REPRESENTATIVE TRIMMED THE EXPULSOR TO CORRECT THE ISSUE AND INSTALLED THE SOFTWARE APPLICATIONS. THE PUMP PASSED ALL FUNCTIONAL TESTS AND PERFORMED AS INTENDED AFTER REPAIR.

    Additional Manufacturer Narrative · 0

    (B)(6). 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 HAD A FAILED ACCURACY TEST +11%. THERE WAS NO CUSTOMER DAMAGE REPORTED, THE DEVICE ISSUE WAS NOT RELATED TO PHYSICAL DAMAGE/ABUSE, AND THERE WAS NO DELAY OF THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216254 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown