BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP

    MDR report key: 8967132 · Received September 5, 2019

    Report

    Report Number
    3012307300-2019-04486
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    November 27, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE CADD LEGACY PUMP WAS RETURNED FOR INVESTIGATION IN GOOD CONDITION. A REVIEW OF THE EVENT HISTORY LOG EVIDENCED THE FOLLOWING: "0491> STARTING LL0 8/12/2019 2:35:00 PM. 0492> HIGH PRESSURE 8/12/2019 2:36:00 PM. 0493> ALARM COMPLETE 8/12/2019 2:36:00 PM. THE INVESTIGATOR RAN THE PUMP IN USER AND PMU MODES. THE INVESTIGATOR ALSO RAN THE PRESSURE CHECK AND TESTED THE DSO/USO SENSORS. THE CUSTOMER REPORTED ISSUE OF THE "HIGH PRESSURE" PROBLEM WAS NOT DUPLICATED. RUNNING THE PUMP IN USER MODE GENERATED NO ISSUES EITHER WITH HIGH PRESSURE, NO DISPOSABLE, OR OTHER ERRORS BASED ON A FAULTY DSO SENSOR. THE UNIT PASSED ALL TESTING IN PMU MODE RELATIVE TO BOTH DSO AND USO SENSORS. A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PUMP, THE PUMP EXHIBITED "HIGH PRESSURE" ALARM. SUBSEQUENTLY, THE PATIENT SWITCHED TO BACKUP PUMP. REPORTED THAT INFUSION IS LIFE-SUSTAINING. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760335 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability