BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP CADD MS3

    MDR report key: 8696638 · Received June 12, 2019

    Report

    Report Number
    MW5087342
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 5, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT INCREASED DOSE TO 17.5 NKM BUT EXPERIENCED INCREASED PULSE. PT DECREASED DOSE TO 16.5 NKM AND PULSE RETURNED TO NORMAL. PT WILL ATTEMPT TO INCREASE AGAIN. PT ALSO REPORTED PUMP SN (B)(4) RAN OUT EARLY ON TWO SEPARATE OCCASIONS, AND ONE OCCASION WAS AFTER PUMP RATE WAS DECREASED. SENDING REPLACEMENT PUMP. NO OTHER INFO AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487062 PUMP CADD MS3 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 99999

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR