BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 13266023 · Received January 17, 2022

    Report

    Report Number
    3012307300-2022-00830
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Report Date
    May 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE PUMP WAS IN GOOD CONDITION. REVIEW OF THE EVENT HISTORY LOG SHOWED OCCURRENCES OF ERROR CODE 1210 AND "SERVICE DUE" MESSAGES. THE REPORTED ISSUES WERE FOUND DURING THE INVESTIGATION. THE INVESTIGATION DETERMINED THAT A DEFECTIVE MICROPROCESSOR UNIT BOARD. WAS THE CAUSE OF THE REPORTED ISSUE. BASED ON EVIDENCE AND INVESTIGATION, THE COMPLAINT ALLEGATION WAS CONFIRMED. THE MICROPROCESSOR UNIT BOARD WAS REPLACED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD LEGACY PLUS, MDL 6500, PUMP EXHIBITED SERVICE ALARM ERROR 1201660.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858946 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown