BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19388144 · Received May 23, 2024

    Report

    Report Number
    2110898-2024-00021
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 23, 2024
    Manufacturer
    3M COMPANY
    Product Code
    BSB
    UDI-DI
    10707387792685
    PMA / PMN Number
    K973741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS. SOLVENTUM IS UNABLE TO VERIFY THE LEAK, IDENTIFY EXACT LOCATION AND ROOT CAUSE WITHOUT THE SAMPLE. BASED ON THE PROBLEM DESCRIPTION AND PHOTO PROVIDED, A LIKELY CAUSE IS A HEAT EXCHANGER LEAK. POSSIBLE CAUSES OF HEAT EXCHANGER LEAKS INCLUDE OVER-PRESSURIZATION ABOVE 300MMHG, INSERTION OR REMOVAL OF PRESSURIZED HEAT EXCHANGER FROM HEATING UNIT, AND HEAT EXCHANGER NOT FULLY INSERTED INTO THE HEATING UNIT. 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. THERE IS NO CHANGE IN TRENDING FOR HEAT EXCHANGER LEAKS. SOLVENTUM WILL CONTINUE TO MONITOR.

    Additional Manufacturer Narrative · 0

    MDR 2110898-2024-00021 SUBMITTED ON 23-MAY-2024 NOTED THE FOLLOWING: SECTION D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). CORRECTION: SECTION D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE WAS RETURNED TO SOLVENTUM FOR ANALYSIS. THE SAMPLE CONFIRMED THERE WAS A LEAK AT THE HEAT EXCHANGER. CAUSE AND TIMING OF THE LEAK COULD NOT BE DETERMINED. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE PROXIMAL END OF THE CASSETTE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244791 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET WARMER, BLOOD, NONELECTROMAGNETIC RADIATION BSB 3M COMPANY 24355 HX9304 10707387792685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown