BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 20713853 · Received November 18, 2024

    Report

    Report Number
    3012307300-2024-13526
    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
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. A REVIEW OF THE EVENT HISTORY LOG DID NOT CONFIRM, THE REPORTED PROBLEM. VISUAL INSPECTION FOUND, CONTAMINATION ON THE DOWNSTREAM OCCLUSION (DSO) SENSOR. FUNCTIONAL TESTING NOTED, A SYSTEM FAULT 44510. THE DSO SENSOR AND THE MAIN BOARD WERE REPLACED. 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
    2595784 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown