BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 20091728 · Received August 28, 2024

    Report

    Report Number
    3012307300-2024-08272
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 11, 2024
    Report Date
    October 14, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE AS RETURNED FOR REPAIR IN USED CONDITION. DEVICE EVENT LOG/ALARM HISTORY WAS REVIEWED AND FOUND ERROR CODE 41171. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. PRIMARY PROBLEM COULD NOT BE CONFIRMED. DEVICE PASSED SELF-TEST WITH NO ALARMS. FOUND THAT THE DEVICE HAD A LIFTING UPSTREAM OCCLUSION (USO) AND DOWNSTREAM OCCLUSION (DSO) SEAL. REPLACED LENS, DSO, AND USO SEAL. DEVICE PASSED ALL TESTING.

    Additional Manufacturer Narrative · 0

    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 WHEN THE PUMP POWERED ON IT ALARMED 41171 4100-257-1991. THIS OCCURRED DURING TESTING, AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191109 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown