BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 14195569 · Received April 22, 2022

    Report

    Report Number
    MW5109338
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Report Date
    April 1, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER PATIENT CADD MS3 PUMP WITH SERIAL NUMBER (B)(4) LOST PROGRAMMING AND PATIENT STATED ONE OF HER CLEO TUBING WOULD NOT DETACH FROM THE CANNULA AND HAD TO USE IT FOR 3 MIXES, POSSIBLE LOT NUMBER COULD BE 4063676. PATIENT DID NOT REPORT ANY SIDE EFFECTS AND DOES NOT HAVE THE DEFECTIVE TUBING ON HAND DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? PUMP NO/ TUBING YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? PUMP YES/TUBING NO. DID WE REPLACE DEVICE? YES. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE T SWITCH TO? YES IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(4) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479280 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 7400 4063676

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CADD PUMP MS3