BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP

    MDR report key: 17654820 · Received August 30, 2023

    Report

    Report Number
    3012307300-2023-08536
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Report Date
    November 20, 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
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, GIVEN THIS NEW INFORMATION A RISK ASSESSMENT WAS PERFORMED THERE WAS 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. 3012307300-2023-08536 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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. B3: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE EXHIBITED ERROR CODE 41622. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415883 CADD SOLIS VIP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown