BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD SOLIS VIP PUMPS - 2120

    MDR report key: 16689520 · Received April 6, 2023

    Report

    Report Number
    3012307300-2023-03633
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    March 14, 2023
    Report Date
    February 8, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    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

    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 MOST PROBABLE CAUSE IS PROGRAMMING ERROR; HOWEVER, THIS CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE SERVICE HISTORY REVIEW IDENTIFIED NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. EMAIL IS: [email protected]

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF FILE CC-0190595, IT WAS DISCOVERED THAT THE FILE WAS INADVERTENTLY ASSESSED AS MALFUNCTION. THE PATIENT WAS HOSPITALIZED AND TREATED FOR ADVERSE EFFECTS RELATED TO THE COMPLAINT EVENT. FILE CC-0190595 IS NOW CONSIDERED AN ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP INFUSED FOR OVER 6 HOURS. THE PUMP WAS MIS PROGRAMMED, THE PATIENT RECEIVED THE ANTIDOTE, AT THE TIME OF THE CALL, THE PATIENT WAS IN THE HOSPITAL FOR EVALUATION OF CHEST PAIN, PATIENT WAS EXPERIENCING SIDE EFFECTS FROM THE OVER INFUSION. THE PATIENT WAS ADVERSELY AFFECTED AND REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869371 CADD SOLIS VIP PUMPS - 2120 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 21-2120-0105-01 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H