BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELZER UW COLD STORAGE SOLUTION

    MDR report key: 7269393 · Received February 14, 2018

    Report

    Report Number
    7269393
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 13, 2018
    Manufacturer
    PRESERVATION SOLUTIONS INC.
    Product Code
    KDN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORGAN RECIPIENT WAS AVAILABLE FOR A KIDNEY TRANSPLANT PROCEDURE. WHEN THE COLD STORAGE SOLUTION WAS OPENED, IT WAS DETERMINED TO HAVE A "ROTTEN EGG" ODOR. ANOTHER BAG OF THE SAME LOT WAS THEN OPENED AND THE FLUID ALSO HAD THE "ROTTEN EGG" SMELL. THE KIDNEY WAS IN CONTACT WITH THE COLD STORAGE SOLUTION. THE TRANSPLANT PATIENT DECLINED THIS ORGAN AND THE KIDNEY WAS NOT USED DURING THE CASE. OPO WAS MADE AWARE OF THE EVENT FOLLOWING DISCUSSION WITH HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113069 BELZER UW COLD STORAGE SOLUTION SYSTEM, PERFUSION, KIDNEY KDN PRESERVATION SOLUTIONS INC. BCD11212117B

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT PRE-OPERATIVE FOR KIDNEY TRANSPLANT