BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUP CADD MS3

    MDR report key: 8574061 · Received May 1, 2019

    Report

    Report Number
    MW5086350
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 22, 2019
    Report Date
    April 22, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT'S DAUGHTER CALLED SPONTANEOUSLY TO REPORT THAT BACKUP PUMP (SN# (B)(4)) HAS LOST ITS PROGRAMMING. PT WILL CONTINUE USING CURRENT FUNCTIONING PUMP. NO INTERRUPTION IN THERAPY, NO HARM TO PT. REPLACEMENT PUMP AND RETURN BOX SENT. PUMP IS BEING REPLACED; NO ADVERSE EFFECT RESULTED DUE TO PUMP MALFUNCTION, PT USED BACKUP PUMP. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360998 PUP CADD MS3 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR