BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 20471085 · Received October 17, 2024

    Report

    Report Number
    3012307300-2024-11341
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 17, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150391
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE: (B)(6). H3, H6: THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER VISUAL INSPECTION, FUNCTIONAL TESTING, AND EVENT HISTORY LOG (EHL) REVIEW, THE CUSTOMER PROBLEM WAS DUPLICATED. THE CAUSE OF THE CUSTOMER REPORTED PROBLEM WAS A DEFECTIVE DOWNSTREAM OCCLUSION (DSO) SENSOR, AND DURING TESTING THE MANUFACTURER INVESTIGATOR ALSO FOUND A DEFECTIVE UPSTREAM OCCLUSION (USO) SENSOR. THE PUMP WAS IN GOOD CONDITION. 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 REPLACED THE DSO SENSOR AND USO SENSOR. H10: RELATED REPORT # 3012307300-2024-11337-00.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOME SCREEN OF THE DEVICE INDICATED A HIGH PRIORITY ALARM / DOWNSTREAM OCCLUSION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463634 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown