BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMPS 6500

    MDR report key: 16521567 · Received March 10, 2023

    Report

    Report Number
    3012307300-2023-02273
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    December 15, 2022
    Report Date
    March 27, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    ADDITIONAL INFORMATION PROVIDED IN B5 AND H6. 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-0180008 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD MDRS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP ALARMED HIGH PRESSURE. NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    EVENT OCCURRED DURING TESTING OF THE UNIT AND THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308309 CADD LEGACY PLUS PUMPS 6500 PUMP, INFUSION FRN ST PAUL 21-6500-51 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown