BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET

    MDR report key: 23335656 · Received October 20, 2025

    Report

    Report Number
    2110898-2025-00064
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 20, 2025
    Manufacturer
    3M COMPANY
    Product Code
    BSB
    UDI-DI
    10707387792685
    PMA / PMN Number
    K973741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNUSED SETS FROM THE SAME LOT WERE RECEIVED FOR ANALYSIS. THE REPORTED ISSUE WAS NOT CONFIRMED, ALL SAMPLES PASSED SPECIFICATIONS. THE ROOT CAUSE OF THE ALLEGED MALFUNCTION COULD NOT BE DETERMINED. POSSIBLE CAUSES INCLUDE PULLING ON TUBING INSTEAD OF HOLDING ON TO THE SPIKE, EXCESSIVE TWISTING OF SPIKE, EXCESSIVE FORCE ON TUBING WHEN REMOVING SPIKE FROM INFUSION BAG, OR OVER PRESSURIZATION OF SET ABOVE 300 MMHG. A REVIEW OF THE BATCH RECORD SHOWED THIS LOT MET ALL SPECIFICATION FOR PRODUCT RELEASE AND NO DEVIATIONS WERE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED MALFUNCTION. SOLVENTUM WILL CONTINUE TO MONITOR.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THREE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS LEAKED WHILE USING A RAPID INFUSER. THERE WAS A CODE TRANSFUSION IN THE INTENSIVE CARE UNIT AND TWO DIFFERENT SETS OF TUBING SEPARATED AT THE SPIKE AND TUBE CONNECTION, RESULTING IN TWO STAFF MEMBERS GETTING BLOOD ON THEIR FACE. THIS ALSO OCCURRED DURING A CODE TRANSFUSION IN THE EMERGENCY DEPARTMENT EARLIER IN THE WEEK, RESULTING IN EXPOSURE TO A STAFF MEMBER. NO INJURIES OR MEDICAL INTERVENTIONS WERE INDICATED DUE TO THE ALLEGED MALFUNCTIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 22-SEP-2025 INDICATING THE LEAK IN THE EMERGENCY DEPARTMENT OCCURRED ON (B)(6) 2025. ISSUE REGARDING TWO LEAKS IN INTENSIVE CARE UNIT IS INVESTIGATED UNDER MDR 2110898-2025-00060. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14921 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET WARMER, BLOOD, NONELECTROMAGNETIC RADIATION BSB 3M COMPANY 24355 HX9911 10707387792685

    Patients

    Seq Age Sex Outcome Treatment
    1