BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 22728753 · Received August 6, 2025

    Report

    Report Number
    2016493-2025-103037
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    April 29, 2025
    Report Date
    November 26, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811043
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISREGARD THE INITIAL REPORT MFR REPORT #2016493-2025-103037. AFTER FURTHER REVIEW OF THE FILE IT WAS DETERMINED THAT THIS FILE IS NOT A REPORTABLE COMPLAINT AND THE MDR WAS SUBMITTED IN ERROR.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THE STATED ISSUES ASSOCIATED TO BARREL CLAMP FRICTION (SCRAPING), ALSO REPORTED AS AN AUDIBLE SCRAPING, WERE CONFIRMED ON ALL 50 RETURNED SYRINGE MODULES. THE FRICTION CAN BE EXHIBITED AS A RESULT OF THE MECHANICAL DESIGN WHERE CONTACT BETWEEN THE BARREL CLAMP PARK COLLAR AND THE INTERNAL FRAME WASHER OCCURS, AND THE CLAMP IS ROTATED PAST THE SYRINGE CHAMBER DURING ITS PARKED POSITION. ON 11JUL2025, (50) SYRINGE MODULES WERE RECEIVED UNBOXED AND WITH PAPERWORK. NO PHYSICAL DAMAGE WAS OBSERVED WITH EACH DEVICE; HOWEVER, ADHESIVE RESIDUE WAS NOTED ON THE TOP OF ALL REAR CASES. THE SYRINGE MODULES WILL BE RETURNED TO BD SAN DIEGO REPAIR CENTER FOR NORMAL PROCESSING AND TO REPLACE THE INTERNAL FRAMES. THE REPORT OF THE INVESTIGATION TO BE ATTACHED TO SALESFORCE. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SCRAPING NOISE ON THE BARREL CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SCRAPING NOISE ON THE BARREL CLAMP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528295 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown