BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMPS

    MDR report key: 16673666 · Received April 4, 2023

    Report

    Report Number
    3012307300-2023-03483
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 15, 2023
    Report Date
    June 30, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    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

    WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0190555 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS ANY REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP WOULD NOT PRIME OR RUN WITHOUT THE DOWNSTREAM OCCLUSION ALARM OCCURRING WITH THE DISPOSABLE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386752 CADD SOLIS VIP PUMPS PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 21-2120-0105-01 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown