BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMPS - 6500

    MDR report key: 16665856 · Received April 3, 2023

    Report

    Report Number
    3012307300-2023-03418
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Report Date
    May 12, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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-0190287 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: CORRECTED DATA PROVIDED IN D4 (SERIAL NUMBER).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP HAS A LED 1230 ERROR. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO ISSUE INVOLVING A PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102396 CADD LEGACY PLUS PUMPS - 6500 PUMP, INFUSION FRN ST PAUL 21-6500-51 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown