BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS EXTENSION SET

    MDR report key: 19851533 · Received July 29, 2024

    Report

    Report Number
    9616066-2024-01052
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 1, 2024
    Report Date
    September 20, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403233647
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THERE IS A LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10011865 LOT NUMBER 24029420 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 14103 UNITS IN 1 LOT NUMBER WAS BUILT ON 20FEB2024. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. 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 BD ALARIS EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT PT. HAD MILRINONE AND EPINEPHRINE RUNNING THROUGH RED LUMEN ON LADLPICC. PTS O2 STARTED TO DECREASED BELOW GOAL AND R. FLANK NIRS WAS 40. PROVIDER NOTIFIED AFTER THIS RN INCREASED O2 REQUIREMENTS WITH NO CHANGES IN PTS. VS. RN LOOKED AT IV TUBING AND NOTICED THAT THE MICRO-FILTERS SEEMED TO BE LEAKING. THIS RN CALLED RESOURCE AND SAQ, AND PROVIDER CAME TO BEDSIDE. MICRO-FILTERS WERE REMOVED, AND NEW ONES WERE PLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995293 BD ALARIS EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24029420 10885403233647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown