BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 21774064 · Received April 4, 2025

    Report

    Report Number
    3012307300-2025-03767
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 1, 2025
    Report Date
    June 16, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D3: MFG ESTABLISHMENT NAME; ICU MEDICAL, INC. DEVICE EVALUATION: NO PRODUCT RETURNED FOR DEVICE ANALYSIS; A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B3: MARCH IS THE REPORTED MONTH, BUT THE EXACT DAY WAS NOT REPORTED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NO SOUND AT ALL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262747 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown