BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP 1.5MG/ML

    MDR report key: 8074976 · Received November 14, 2018

    Report

    Report Number
    MW5081331
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 28, 2018
    Report Date
    October 28, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CADD LEGACY PUMP MALFUNCTION WITH HIGH PRESSURE AND LOW BATTERY. NO OCCLUSION IN TUBING WITH NEW BATTERIES. PT SWITCHED TO BACK UP DEVICE WITH ADEQUATE BATTERIES TO RESOLVE ISSUE. NO ADVERSE EVENT ASSOCIATED WITH THIS PRODUCT COMPLAINT. REPORTED TO (B)(6) BY PT/CAREGIVER. DOSE OR AMOUNT: 20 NKM, FREQUENCY: CONTINUOUS, ROUTE: INTRAVENOUS. DATES OF USE: FROM (B)(6) 2017 TO CURRENT. DOSE OR AMOUNT: 20 NKM, FREQUENCY: CONTINUOUS, ROUTE: INTRAVENOUS. DATES OF USE: FROM "(B)(6) 2017" TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907758 CADD LEGACY PUMP 1.5MG/ML PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR