BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDSENSE ALARM UNIT AND SENSOR

    MDR report key: 9601327 · Received January 17, 2020

    Report

    Report Number
    9601327
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 26, 2019
    Report Date
    December 30, 2019
    Manufacturer
    REDSENSE MEDICAL AB
    Product Code
    ODX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT ON SHIFT THERAPY WITH ACCESS IN HIS AV FISTULA, WITH 45 MINUTES LEFT IN TREATMENT THE PATIENT WAS FOUND TO BE COVERED IN A DECENT AMOUNT OF BLOOD FROM HIS FISTULA. THE NEW SENSOR THAT IS PLACED TO DETECT A LEAK DID NOT ALARM WHEN THE SITE BEGAN TO BLEED AND WAS ONLY DISCOVERED WHEN THE CA WENT TO CHECK ON HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66365 REDSENSE ALARM UNIT AND SENSOR AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM ODX REDSENSE MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1