BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDIVANCE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 8257316 · Received January 17, 2019

    Report

    Report Number
    MW5083206
    Event Type
    Death
    Date Received
    January 17, 2019
    Date of Event
    December 15, 2018
    Report Date
    December 31, 2018
    Manufacturer
    MEDIVANCE / C. R. BARD, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT DX'D W/ INTRAPARENCHYMAL HEMORRHAGE AND ON ARCTIC SUN DEVICE W/ TEMPERATURE SENSING FOLEY PROBE. PROBE MALFUNCTIONED INDICATING PT HYPOTHERMIC INSTEAD OF FEBRILE, AND PT NOT PROPERLY COOLED. HOT WATER HAD BEEN INSTILLED BY ARCTIC SUN DEVICE INSTEAD OF COLD WATER. (ARCTIC SUN DISPLAYED TEMP AS 97.5 BUT PT FELT HOTTER. FOLEY CHANGED AND TEMP DISPLAYED AS 106.51). ICED NML SALINE, IV TYLENOL, AND ANTIBIOTICS ADMINISTERED. PT THEREAFTER PRONOUNCED BRAIN DEAD ON (B)(6) 2018 AT 5:50 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52152 MEDIVANCE ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM SYSTEM, THERMAL REGULATING DWJ MEDIVANCE / C. R. BARD, INC. 5000
    52153 BARD LUBRI-SIL I. C. TEMPERATURE SENSING FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL C. R. BARD, INC. PK7645767 NGCU2079

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death| L| R| S