BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANGER STANDARD FLOW DISPOSABLE SET

    MDR report key: 3899897 · Received June 3, 2014

    Report

    Report Number
    3899897
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    3M COMPANY
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOUR MINUTES INTO TPE (THERAPEUTIC PLASMA EXCHANGE), BLOOD WAS OBSERVED AT THE JOINT OF THE AIR BUBBLE CHAMBER AND THE TUBING. PROCEDURE WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325330 RANGER STANDARD FLOW DISPOSABLE SET TUBING, WARMER, THERMAL, INFUSION FLUID LGZ 3M COMPANY RANGER 24250 E7333

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR