BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-LEGACY® 1 PUMP

    MDR report key: 8006388 · Received October 25, 2018

    Report

    Report Number
    3012307300-2018-02090
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    October 4, 2018
    Report Date
    January 2, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THIS EVENT OCCURRED DURING TESTING AND THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP SHOWED THAT THE PUMP WAS IN GOOD PHYSICAL CONDITION. THE PUMP EVENT LOG NOTED MULTIPLE 'NO DISPOSABLE' ALARM MESSAGES WERE RECORDED. FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS STARTED IN APPLICATION AND A 'NO CASSETTE DETECTED' ALARM MESSAGE WAS UNABLE TO BE DUPLICATED. HOWEVER, WHEN A CASSETTE WAS REMOVED FROM THE PUMP, THE PUMP EXHIBITED A 'NO DISPOSABLE ATTACHED' ALARM MESSAGE. SENSOR TESTING FOUND THE DOWNSTREAM OCCLUSION SENSOR VALUE WAS WITHIN MANUFACTURING SPECIFICATION. THE UPSTREAM OCCLUSION SENSOR WAS RECALIBRATED AND THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED. BASED ON THE EVIDENCE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE OBSERVATION WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS AMBULATORY INFUSION PUMP EXHIBITED A DOUBLE BEEP ALARM FOR NO CASSETTE. IT WAS NOT SPECIFIED WHETHER OR NOT THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844987 CADD® CADD-LEGACY® 1 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1