BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS GRAVITY SET

    MDR report key: 23205736 · Received October 2, 2025

    Report

    Report Number
    9616066-2025-02912
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 22, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K050115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THREE PHOTOS RECEIVED, ONE PHOTO OF THE PRODUCT FAILURE. EVALUATION OF THE PHOTOS PROVIDED INDICATE THAT THE INFUSION SETS SEPARATED. FURTHER INSPECTION OF THE PHOTO INDICATE THAT THERE IS NO EVIDENCE OF SOLVENT AT THE END OF THE SEPARATED TUBING. THE CUSTOMER COMPLAINT OF SEPARATION WAS CONFIRMED. INVESTIGATION OF THE PHOTOS FOR ROOT CAUSE OF THE FAILURE HAS BEEN FORWARDED TO MANUFACTURING. AFTER THE INVESTIGATION IT WAS DETERMINED THAT THE ISSUE COULD BE RELATED TO THE LACK OF SOLVENT APPLIED TO THE TUBING AND INCORRECT USE OF THE ASSEMBLY FIXTURE BY THE ASSEMBLER AS ESTABLISHED BY THE WORK INSTRUCTIONS. THERE WERE NO ADDITIONAL ACTIONS TAKEN AT THE FACILITY THAT PRODUCED THE PRODUCT AS THE PRODUCT WILL NOT LONGER BE PRODUCED AT THAT LOCATION. ADDITIONALLY, A QUALITY ALERT WAS CREATED TO COMMUNICATE THE FAILURE AND REINFORCE THE CORRECT SOLVENT APPLICATION METHOD TO THE ASSEMBLY PERSONNEL, AT THE NEW PRODUCTION LOCATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10010903 LOT NUMBER 24059430 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS GRAVITY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPIKES FELL OFF OF TUBING, ON ONE BLOOD WAS SPIKED AND THEN SPIKE FELL OFF WITH BLOOD ON IT, 2 OTHER SPIKES FELL OFF THIS LED TO A CRITICAL DELAY IN BLOOD ADMINISTRATION WITH A TRAUMA PT REQUIRING BLOOD IMMEDIATELY. PATIENT INJURY: NO. QTY AFFECTED: (B)(4) EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276757 BD ALARIS GRAVITY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 24059430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown