BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 19391480 · Received May 24, 2024

    Report

    Report Number
    9616066-2024-00791
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 3, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES - FLUID BLOCKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: NURSES IN L&D REPORT FREQUENT PATIENT SIDE OCCLUSION ALARMS WHILE INFUSING PITOCIN AS A PRIMARY INFUSION, Y-SITED INTO A PRIMARY INFUSION OF LR. THE LR PUMP MODULE INFUSES WITHOUT ALARM WHILE THE PITOCIN PUMP MODULE ALARMS PATIENT SIDE OCCLUSION. I EDUCATED THE NURSES ON L&D AND MBU ON THE PROPER WAY TO MAKE A Y-SITE CONNECTION AND HOW TO CHANGE PRESSURE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688733 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown