BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 18271076 · Received December 5, 2023

    Report

    Report Number
    3012307300-2023-12002
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 1, 2023
    Report Date
    February 13, 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
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RETURNED TO MFG: (B)(6) 2024 DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE DOWNSTREAM OCCLUSION SENSOR SEAL WAS BUBBLED, THE UPSTREAM OCCLUSION SEAL WAS WORN AND THE LENS WAS SCRATCHED. FUNCTIONAL TESTING DUPLICATED THE REPORTED ISSUE. ACCURACY TESTING FOUND THAT THE PUMP WAS OVER DELIVERING. THE INVESTIGATION DETERMINED THAT THE EXPULSOR WAS THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE. THE EXPULSOR WAS REPLACED. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.G1

    Additional Manufacturer Narrative · 0

    H3: DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. B3 IS UNKNOWN, INFORMATION WAS NOT PROVIDED BY REPORTER.

    Description of Event or Problem · 0

    GCM RECEIVED A MOAK COMPLAINT VIA SERVICE CLOUD ON 30-NOV-2023 FROM DOMINIKA WINCZA, INTEGRATED MEDICAL SYSTEMS INC, REGARDING PUMP, CADD-LEGACY PLUS, MDL 6500 WITH LN 21-2120-0102-51 SN (B)(6) IT WAS STATED THAT THE DEVICE WAS OVERINFUSING DURING TEST. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. LGABATO 30-NOV-2023

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123177 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown