BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 20706157 · Received November 18, 2024

    Report

    Report Number
    3012307300-2024-13449
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 17, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RETURNED FOR REPAIR WITH COMPLAINT OF CASSETTE NOT ATTACHED ERROR. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS 12 MONTHS. REPORTED PROBLEM COULD NOT BE DUPLICATED. THE PROBLEM WAS CONFIRMED WITH EVENT LOG HISTORY. VISUAL INSPECTION FOUND MODERATE BUBBLING OF THE DOWNSTREAM OCCLUSION (DSO) SEAL. CONTAMINATION WAS FOUND AT DSO SENSOR AREA AND AT LATCH/LOCK AREA. THE PROBABLE CAUSE OF THE REPORTED PROBLEM CONTAMINATION. REPLACED DSO SENSOR AND LCD LENS. AFTER REPAIR ALL FUNCTIONAL TEST OF THE PUMP PASSED.

    Additional Manufacturer Narrative · 0

    E1: PHONE EX (B)(6). A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    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
    2036450 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown