BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW

    MDR report key: 15659724 · Received October 24, 2022

    Report

    Report Number
    2110898-2022-00102
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Report Date
    December 8, 2022
    Manufacturer
    3M HEALTH CARE
    Product Code
    BSB
    UDI-DI
    00707387781446
    PMA / PMN Number
    K973741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT SPECIFICS ARE UNKNOWN. DATE OF EVENT IS UNKNOWN. INITIAL REPORTER OCCUPATION IS UNKNOWN. PRODUCT HAS NOT BEEN RETURNED TO 3M¿ FOR ANALYSIS. 3M¿ IS UNABLE TO VERIFY THE LEAK, IDENTIFY EXACT LOCATION AND ROOT CAUSE WITHOUT THE SAMPLE. 3M¿ WILL CONTINUE TO MONITOR.

    Additional Manufacturer Narrative · 0

    MDR-2110898-2022-00102 SUBMITTED ON 24-OCT-2022 NOTED THE FOLLOWING: E1 INITIAL REPORTER: 1. NAME: (B)(6). 2. ADDRESS: (B)(6). TELEPHONE:(B)(6). G2 REPORT SOURCE: FOREIGN. G3 DATE RECEIVED BY MANUFACTURER: 03-OCT-2022. CORRECTIONS E1 INITIAL REPORTER: 1. NAME: (B)(6). 2. ADDRESS: (B)(6). TELEPHONE: (B)(6). G2 REPORT SOURCE: FOREIGN WAS UNSELECTED AS NOT APPLICABLE. G3 DATE RECEIVED BY MANUFACTURER: 07-OCT-2022. BASED ON THE CORRECTIONS PROVIDED, 3M'S ASSESSMENT REMAINS THE SAME; THE PRODUCT HAS NOT BEEN RETURNED TO 3M¿ FOR ANALYSIS. 3M¿ IS UNABLE TO VERIFY THE LEAK, IDENTIFY EXACT LOCATION AND ROOT CAUSE WITHOUT THE SAMPLE. 3M¿ WILL CONTINUE TO MONITOR.

    Additional Manufacturer Narrative · 0

    LEAK LOCATION WAS REPORTED TO BE AT THE BUBBLE TRAP. 3M¿ HAS INVESTIGATED AND IDENTIFIED A MANUFACTURING ISSUE WITH THE AUTO-VENTING BUBBLE TRAP THAT INTRODUCES THE RISK OF BLOOD OR FLUID LEAKS WHILE PRIMING THE SETS AND/OR DURING FLUID ADMINISTRATION. THERE IS NO ALLEGED INJURY TO THE PATIENT OR CAREGIVER FOR THIS REPORTED INCIDENT. 3M¿ HAS INITIATED A FIELD SAFETY CORRECTIVE ACTION FOR LOTS ASSOCIATED WITH THIS ISSUE. 3M¿ HAS IMPLEMENTED A CHANGE TO ADDRESS THE IDENTIFIED MANUFACTURING ISSUE AND WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    A HOSPITAL ALLEGED THE 3M¿ RANGER¿ HIGH FLOW WARMING SET (MODEL 24355) LOT HX9181 LEAKED DURING USE. NO PATIENT OR STAFF INJURY WAS ALLEGED. NO MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016466 3M¿ RANGER¿ FLUID WARMING SET, HIGH FLOW HIGH FLOW DISPOSABLE TUBING BSB 3M HEALTH CARE 00707387781446

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown