BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 21835822 · Received April 14, 2025

    Report

    Report Number
    3012307300-2025-04231
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D3 - MFG ESTABLISHMENT NAME, H3 AND H6. CODES: UPDATED. DEVICE EVALUATION: THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THE ISSUE OF "FAILED DOWNSTREAM OCCLUSION (DSO) CALIBRATION¿ WAS NOT CONFIRMED THROUGH, DSO AND UPSTREAM OCCLUSION (USO) CALIBRATION. FURTHER INVESTIGATION FOUND DSO AND USO SEAL DELAMINATED, LIQUID CRYSTAL DISPLAY (LCD) LENS NICKED, REAR HOUSING DAMAGED, BATTERY COMPARTMENT CORROSION, BATTERY DOOR CORROSION, AND ODO: 6001712. REPLACED DSO AND USO SEAL, LCD LENS, REAR HOUSING, BATTERY COMPARTMENT, BATTERY DOOR, AND MOTOR. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS 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 HAS A FAILED DSO CALIBRATION, AND IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103835 CADD SOLIS VIP PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown