BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 8001777 · Received October 24, 2018

    Report

    Report Number
    3012307300-2018-01701
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED AND PRODUCT FOUND TO BE IN GOOD CONDITION. CUSTOMER'S COMPLAINT OF UPSTREAM SENSOR OCCLUSION INTERMITTENT WAS VERIFIED. THE EVENT LOG DID SHOW THE ERROR OF UPSTREAM OCCLUSION ON (B)(6) 2018. SERVICE REPLACED THE UPSTREAM OCCLUSION SENSOR. USE TESTING WAS PERFORMED. THE PROBLEM SOURCE IS THE UPSTREAM OCCLUSION SENSOR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE CADD LEGACY PLUS PUMP ALARMS UPSTREAM SENSOR OCCLUSION. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839203 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1