BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 23192848 · Received October 1, 2025

    Report

    Report Number
    3012307300-2025-11136
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. D4 - SERIAL: POSSIBLE # PROVIDED ARE (B)(6). H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IV REMODULIN PUMP (CADD) HAD TURNED OFF FOR AN UNKNOWN REASON. THE PATIENT WAS IN THE HOSPITAL TO BE RESTARTED ON 66 NKM AND WAS PLANNED FOR DISCHARGE ON THE SAME DOSE. THE PATIENT WAS TO INCREASE BY 4 NKM WEEKLY UNTIL REACHING THE GOAL DOSE OF 80 NKM. THE DATE OF ADMISSION AND TARGET DOSE TIMELINE WERE UNKNOWN. NO FURTHER INFORMATION, DETAILS, OR DATES WERE PROVIDED. THE PATIENT WAS TRANSITIONED TO A SOLIS PUMP DURING THE HOSPITAL STAY. THE DEVICE SERIAL NUMBERS (B)(6) AND (B)(6) WERE CHECKED OUT BY THE PATIENT, AND THE EVENT OCCURRED DURING PATIENT USE. IT WAS CONFIRMED THAT THE PRODUCT ISSUE DID NOT CAUSE OR CONTRIBUTE TO ANY CLINICAL INJURY. HOWEVER, IT WAS NOTED THAT THE PATIENT EXPERIENCED A MISSED DOSE OR INTERRUPTION, AS THE PUMP HAD BEEN TURNED OFF IN THE HOSPITAL TO RESTART REMODULIN. PATIENT DETAILS WERE PROVIDED: THE PATIENT'S INITIAL IS (B)(6), A MALE BORN ON (B)(6) 1954, THE DATE OF REPORT WAS ON 03-SEP-25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154724 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male