BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW

    MDR report key: 17916049 · Received October 11, 2023

    Report

    Report Number
    2110898-2023-00086
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Report Date
    June 6, 2024
    Manufacturer
    3M COMPANY
    Product Code
    BSB
    PMA / PMN Number
    K973741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT SECTION D3 MANUFACTURER NAME, CITY AND STATE, FROM 3M HEALTH CARE TO 3M COMPANY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT SECTION D4 MODEL # FROM BLANK TO 24355, AND SECTION D4 UNIQUE IDENTIFIER (UDI) # FROM (B)(4) TO NI.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE HAS NOT BEEN RETURNED TO 3M FOR ANALYSIS. 3M IS UNABLE TO VERIFY THE LEAK, IDENTIFY EXACT LOCATION AND ROOT CAUSE WITHOUT THE SAMPLE AND LEAK LOCATION. POSSIBLE CAUSES OF 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. 3M WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    A HOSPITAL ALLEGED THE TUBING OF 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET, 24355 LEAKED IN THREE DIFFERENT AREAS WHILE PRIMING THE TUBING WITH NORMAL SALINE FOR A BLOOD TRANSFUSION. NO PATIENT OR STAFF INJURY WAS ALLEGED AND NO MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238362 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW BAIR HUGGER BLOOD/FLUID WARMER BSB 3M COMPANY 24355

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown