BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 18043144 · Received October 31, 2023

    Report

    Report Number
    3012307300-2023-10088
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Report Date
    October 31, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: ONE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION SHOWED THE PUMP WAS IN GOOD CONDITION. THE TAMPER SEAL WAS NOT BROKEN. REVIEW OF THE EVENT HISTORY LOG (EHL) SHOWED A RECORD OF REPEATED POWER ON AND OFF, PRESUMABLY CAUSED BY A BEEP SOUND AS AN ALARM BEFORE THE NDA WAS FINALIZED ON SEPTEMBER 13, 2023. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS NOT DUPLICATED. A DEFECTIVE DOWNSTREAM SENSOR OR CASSETTE PRODUCT COULD HAVE CAUSED THE REPORTED ISSUE. AS A PREVENTIVE MEASURE, THE DOWNSTREAM SENSOR AND UPSTREAM SENSOR WERE RE-CALIBRATED. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. B3, D4: UDI, AND G5 ARE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED TWO BEEPS (LONG-SHORT) PRIOR THE NO DISPOSABLE ALARM (NDA) WAS FINALIZED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200253 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown