BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 20712890 · Received November 18, 2024

    Report

    Report Number
    3012307300-2024-13516
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 18, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PHONE EX (B)(6). ONE DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. IT WAS DETERMINED THAT THE EXCESSIVE DEBRIS ON THE DOWNSTREAM OCCLUSION (DSO) SENSOR WAS THE ROOT CAUSE. THE DSO SENSOR ASSEMBLY WAS REPLACED. THE DEVICE THEN PASSED ALL FUNCTIONAL TESTING. THE SERVICE HISTORY REVIEW HAD 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 EXHIBITED A CASSETTE DETECT ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591291 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown