BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAYLOR-WHARTON

    MDR report key: 109526 · Received July 3, 1997

    Report

    Report Number
    109526
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Date of Event
    January 1, 1995
    Report Date
    May 30, 1997
    Manufacturer
    TAYLOR-WHARTON
    Product Code
    JRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SOMETIME IN AUGUST/SEPTEMBER 1995, CONDENSATION BUILT UP INSIDE THE FREEZER CAUSING THE LID TO BE FROZEN IN PLACE ABOVE THE NORMAL POSITION. CONSEQUENTLY THE LID WAS REPLACED. IN MARCH 1997, THE LID REPLACEMENT BEGAN TO SHOW SIGNS OF LIFTING WITH ACCUMULATED ICE BUILD-UP. A NEW FREEZER WAS ORDERED AND TRANSFER OF BONE MARROW PRODUCT INITIATED ON 5-9-97. DURING THE PROCESS OF TRANSFERRING PRODUCT TO THE NEW FREEZER IT WAS NOTED THAT SOME OF THE PRODUCT BAGS HAD LEAKED AND NOW CONTAINED LIQUID NITROGEN. DURING MONTH OF APRIL 1997, FREEZER ALARM WOULD GO OFF INDICATING NEED FOR MORE LIQUID NITROGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAYLOR-WHARTON LIQUID NITROGEN STORAGE FREEZER JRM TAYLOR-WHARTON K SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other GAMBRO BAGS