BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD ALARIS EXTENSION SET

    MDR report key: 24604505 · Received March 16, 2026

    Report

    Report Number
    9616066-2026-00654
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 30, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403233647
    PMA / PMN Number
    K790108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX A CODE. H10: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MATERIAL 10011865 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS EXTENSION SET HAD AIR IN LINE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE LARGE AMOUNT OF AIR EMBOLI. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NNP CALLED TO BEDSIDE TO ASSESS LEFT ARM WITH ALINE. MOTTLING NOTED THROUGHOUT ARM, CHEST, AND BACK ALONG WITH DEC PERFUSION TO HAND. ALINE REMOVED. ULTRASOUNDS OBTAINED OF LUE AND HUS. LARGE AMOUNT OF AIR EMBOLI NOTED ON HUS. PT WITH WORSENING LACTATE ACIDOSIS AFTER RECEIVING MEDICATIONS AND INTUBATION. REPEAT HUS, CT, AND MRI WITH EXTENSIVE BRAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269779 BD ALARIS EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 10885403233647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death