BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 11528829 · Received March 18, 2021

    Report

    Report Number
    MW5100115
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 18, 2021
    Report Date
    February 18, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS. PATIENT STATES THAT WHILE SHE WAS ATTEMPTING TO CHANGE HER CARTRIDGE, THERE WAS NOTHING FLOWING OUT OF THE NEW TUBING SET. SHE STATES THE PUMP IS RUNNING, BUT NO REMODULIN FLOWING OUT OF TUBING. NO ALARMS ON PUMP. TUBING LOT #4063676. PATIENT CHANGED OUT TUBING TO ANOTHER SET, WITH SAME LOT# AND NO ISSUES. NO OTHER INFORMATION KNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? PLEASE EXPLAIN. N/A. IS THE ACTUAL DEVICE IS AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES DID WE REPLACE DEVICE? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419198 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723124
    419199 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR