BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS CADD SET 21-7394-24

    MDR report key: 12086749 · Received June 28, 2021

    Report

    Report Number
    MW5102187
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 24, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021 (INCIDENT IDENTIFIED BY VNA ON (B)(6) 2021 BUT NOT REPORTED UNTIL (B)(6) 2021) CALL FROM PATIENT CAREGIVER WHO REPORTS PT WAS HOOKED UP TO ABT IN THE HOSPITAL ON FRIDAY ABOUT 430P, WHEN THE RN CAME ON SATURDAY TO ASSIST WITH FIRST HOME BAG CHANGE, THE ABT WAS STILL FULL. THE PCG/RN DO NOT KNOW WHY, THEY DIDN'T THINK TO CALL IN THEN, AND JUST CHANGED THE BAG, DISPOSING THE OLD ONE. THE PUMP HAS BEEN WORKING WITHOUT ISSUE SINCE, PCG WAS SUSPECTING MAYBE A CLAMP WAS CLOSED BUT WE DISCUSSED IF A CLAMP WAS CLOSED THE PUMP WOULD HAVE ALARMED. SHE IS ADVISED TO CHECK THE PUMP PERIODICALLY TO SEE THAT IT IS RUNNING WITH GREEN LIGHT FLASHING AND SHE WILL DO THAT FROM NOW ON. SHE DENIES ANY ISSUE OVER THE WEEKEND AND FEELS SHE IS INDEPENDENT WITH BAG CHANGE. SHE WANTED NELC TO KNOW THE PATIENT MAY HAVE MISSED THE DOSES FROM FRIDAY INTO SATURDAY. SHE IS ADVISED TO CALL INTO TRIAGE WITH ANY ISSUES WHEN THE ISSUE IS HAPPENING AND SHE VERBALIZES UNDERSTANDING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978059 SMITHS CADD SET 21-7394-24 SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.
    978060 SMITHS CADD VIP PUMP, INFUISON FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1