BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 25191148 · Received May 15, 2026

    Report

    Report Number
    1527821-2026-00005
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 15, 2026
    Manufacturer
    STERIS CORPORATION
    Product Code
    FPA
    UDI-DI
    07613203012256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ISOMEDIX OPERATIONS INC. (STERIS AST) RECEIVED MEDWATCH REPORT#: MW5185572 RELATED TO A BD SMARTSITE UNIT. THE PRODUCT IDENTIFIED IN THE MEDWATCH REPORT IS NEITHER MANUFACTURED BY STERIS AST, NOR IS STERIS AST THE APPLICANT HOLDING THE PREMARKET APPROVAL (PMA). THE MEDWATCH REPORT WAS FORWARDED TO THE DEVICE MANUFACTURER ON APRIL 22, 2026, FOR INVESTIGATION AND EVALUATION OF POTENTIAL MEDICAL DEVICE REPORTING UNDER 21 CFR 803. CAREFUSION (BD) CONFIRMED VIA EMAIL THAT AN INTERNAL INVESTIGATION WAS INITIATED UNDER#: (B)(4). COMPLAINT (B)(4) WAS INITIATED BY THE TEMECULA, CA FACILITY. THE INVESTIGATION INCLUDED A BATCH REVIEW OF LOAD ALA-1162-19612 THAT WAS PROCESSED ON NOVEMBER 15, 2025, FOR THE IDENTIFIED PRODUCT AND LOT#: 25105525. NO FAILURES WERE IDENTIFIED DURING THE STERILIZATION PROCESS.

    Description of Event or Problem · 0

    THE AST TEMECULA, CA FACILITY RECEIVED A MEDWATCH REPORT#: MW5185572, INDICATING THE BD SMARTSITE LOW SORBING EXTENSION SET 0.2 MICRON FILTER WAS CLOGGING/MALFUNCTIONING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431923 ALARIS, SMARTSITE LOW SORBING EXTENSION SET FPA STERIS CORPORATION 20350E (10)25105525 07613203012256

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown