BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12324757 · Received August 16, 2021

    Report

    Report Number
    3012307300-2021-08467
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Report Date
    March 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT DEVICE FRONT CASE WAS DAMAGED, ERROR CODE ON POWER UP NEEDS NDA FIRMWARE UPDATE. DEVICE WAS DAMAGED. THE DEVICE WAS POWERED UP AND ALARMED, WHICH IS A CORRUPTION OF THE MEMORY OF THE CIRCUIT BOARD. THE PROBLEM WAS CAUSED BY THE CIRCUIT BOARD. UNABLE TO DETERMINE WHO CAUSED THE PROBLEM. REPLACED CIRCUIT BOARD.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT DEVICE FRONT CASE WAS DAMAGED, ERROR CODE ON POWER UP NEEDS NDA FIRMWARE UPDATE. DEVICE WAS DAMAGED. THE DEVICE WAS POWERED UP AND ALARMED, WHICH IS A CORRUPTION OF THE MEMORY OF THE CIRCUIT BOARD. THE PROBLEM WAS CAUSED BY THE CIRCUIT BOARD. UNABLE TO DETERMINE WHO CAUSED THE PROBLEM. REPLACED CIRCUIT BOARD.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT DEVICE FRONT CASE WAS DAMAGED, ERROR CODE ON POWER UP NEEDS NDA FIRMWARE UPDATE. DEVICE WAS DAMAGED. THE DEVICE WAS POWERED UP AND ALARMED, WHICH IS A CORRUPTION OF THE MEMORY OF THE CIRCUIT BOARD. THE PROBLEM WAS CAUSED BY THE CIRCUIT BOARD. UNABLE TO DETERMINE WHO CAUSED THE PROBLEM. REPLACED CIRCUIT BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FRONT CASE WAS DAMAGED, ERROR CODE ON POWER UP NEEDS NDA FIRMWARE UPDATE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FRONT CASE WAS DAMAGED, ERROR CODE ON POWER UP NEEDS NDA FIRMWARE UPDATE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FRONT CASE WAS DAMAGED, ERROR CODE ON POWER UP NEEDS NDA FIRMWARE UPDATE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD LEGACY PLUS EXHIBITED ERROR CODE 1260 ON POWER UP, HAD A FRONT CASE DAMAGE AND NEEDED NO DISPOSABLE ALARM FIRMWARE UPDATED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224625 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown