BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12442871 · Received September 8, 2021

    Report

    Report Number
    3012307300-2021-09247
    Event Type
    Malfunction
    Date Received
    September 8, 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
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT DEVICE WAS SHOWING BATTERY OCCLUSION SENSOR AND CASSETTE NOT DETECTED. TAMPER SEALS WERE ALL INTACT. PERFORMED FUNCTIONAL CHECK, RAN PUMP WITH RETURNED PROGRAM, NDA TESTING. REPLACED DOWNSTREAM SENSOR, UPSTREAM SENSOR AND CLOCK BATTERY.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT DEVICE WAS SHOWING BATTERY OCCLUSION SENSOR AND CASSETTE NOT DETECTED. TAMPER SEALS WERE ALL INTACT. CUSTOMER PROBLEM WAS NOT DUPLICATED DURING THE INVESTIGATION. PERFORMED FUNCTIONAL CHECK, RAN PUMP WITH RETURNED PROGRAM, PERFORMED NDA TEST. REPLACED DOWNSTREAM SENSOR, UPSTREAM SENSOR AND CLOCK BATTERY.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT DEVICE WAS SHOWING BATTERY OCCLUSION SENSOR AND CASSETTE NOT DETECTED. TAMPER SEALS WERE ALL INTACT. CUSTOMER PROBLEM WAS NOT DUPLICATED DURING THE INVESTIGATION. PERFORMED FUNCTIONAL CHECK, RAN PUMP WITH RETURNED PROGRAM, PERFORMED NDA TEST. REPLACED DOWNSTREAM SENSOR, UPSTREAM SENSOR AND CLOCK BATTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE SHOWED BATTERY OCCLUSION SENSOR AND CASSETTE WAS NOT DETECTED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE SHOWED BATTERY OCCLUSION SENSOR AND CASSETTE WAS NOT DETECTED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE SHOWED BATTERY OCCLUSION SENSOR AND CASSETTE WAS NOT DETECTED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP EXHIBITED SERVICE DUE, RTC BATTERY OCCLUSION SENSOR AND CASSETTE NOT DETECTED ALARM. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340277 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown