BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 20714024 · Received November 18, 2024

    Report

    Report Number
    3012307300-2024-13521
    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
    UDI-DI
    10610586029554
    PMA / PMN Number
    K111275
    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. VISUAL INSPECTION FOUND A DAMAGED DOWNSTREAM OCCLUSION (DSO) SEAL AND A BROKEN BATTERY COMPARTMENT. IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE IS THE DSO SENSOR. THE DSO SENSOR 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 DOWNSTREAM OCCLUSION ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620514 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown