BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARIZANT BAIR HUGGER (TM) WARMING UNIT

    MDR report key: 6876794 · Received September 19, 2017

    Report

    Report Number
    2110898-2017-00117
    Event Type
    Death
    Date Received
    September 19, 2017
    Date of Event
    January 10, 2017
    Report Date
    September 19, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    DWJ
    PMA / PMN Number
    K903360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED BY THE ARTICLE NOR HOSPITAL RISK MANAGER. THE MODEL 500 WAS DISCONTINUED FROM THE MARKET PRIOR TO THE REQUIREMENT OF UDI FDA REQUIREMENTS. THERE IS NO EXPIRATION DATE ON THE HARDWARE ONLY THE DISPOSAL (WARMING BLANKET). 3M IS CHECKING PRODUCTION RECORDS FOR MANUFACTURING DATE OF THE UNIT LINKED TO SERIAL NUMBER. AT THIS TIME THIS INFORMATION IS NOT AVAILABLE. THE WARMING BLANKET (MODEL AND TYPE) USED WAS NOT SPECIFIED. PRODUCT LABELING DOES INCLUDE THE PRECAUTION STATEMENT AS NOTED UNDER PART B OF THIS REPORT ABOUT MONITORING PATIENT. 3M WAS MADE AWARE OF ALLEGED INCIDENT VIA (B)(6) ALERT. THERE WAS AN ARTICLE PUBLISHED BY (B)(6) REAL-TIM NEWS ENTITLED: "(B)(6) MED CITED FOR FAILING TO MONITOR (B)(6) WHO DIED" THE ARTICLE INDICATED THE FOLLOWING: "(B)(6) MEDICAL CENTER HAS BEEN CITED FOR FAILING TO SUFFICIENTLY MONITOR THE TEMPERATURE OF A (B)(6) BOY WHO WAS PLACED UNDER A SPECIAL HEATING BLANKET AND DIED AFTER HIS TEMPERATURE REACHED 107.6 DEGREES, ACCORDING TO THE (B)(6) DEPARTMENT OF HEALTH. THE HEALTH DEPARTMENT FURTHER CITED THE MEDICAL CENTER FOR FAILING TO IMMEDIATELY REPORT THE DEATH TO A STATE AGENCY THAT STUDIES SUCH EVENTS TO PREVENT REPEATS. ACCORDING TO THE HEALTH DEPARTMENT, THE BOY WAS BROUGHT TO THE EMERGENCY ROOM AROUND 3 P.M. ON JAN. 10 WITH A BODY TEMPERATURE OF 89.4 DEGREES. THE AVERAGE NORMAL BODY TEMPERATURE IS 98.6 DEGREES. HE WAS GIVEN A BLANKET-TYPE WARMING DEVICE CALLED A "BAIR HUGGER." 3M CONTACTED THE MEDICAL CENTER FOR FURTHER INFORMATION AND OBTAINED VERY LIMITED INFORMATION. CONTACT NAME OF MEDICAL CENTER: (B)(6) MEDICAL CENTER. END OF REPORT.

    Description of Event or Problem · 1

    A (B)(6) MALE WAS SEEN IN THE HOSPITAL EMERGENCY DEPARTMENT WITH "ONGOING, COMPLEX AND LIFE-LIMITING HEALTH ISSUES". SEPSIS WAS PRESUMED. THE BOY WAS ADMITTED TO THE HOSPITAL. HIS BODY TEMPERATURE WAS 89.4 DEGREES F. HE WAS WARMED WITH A "BLANKET-TYPE WARMING DEVICE CALLED A BAIR HUGGER". THE BOY'S BODY TEMPERATURE WAS MEASURED UNTIL APPROXIMATELY MIDNIGHT WHEN IT WAS 98 DEGREES F. AROUND 10 A.M. THE NEXT DAY THE BOY WAS CHECKED; HE ALLEGEDLY HAD NO VITAL SIGNS. HIS BODY TEMPERATURE WAS NOTED TO BE 107.6 DEGREE F. THE BOY WAS TAKEN TO THE INTENSIVE CARE UNIT WHERE HE DIED. ON SEPTEMBER 12, 2017 THE HOSPITAL RISK MANAGER CONFIRMED THAT THE WARMING DEVICE WAS A BAIR HUGGER¿, MODEL 500. PRODUCT MANUAL INCLUDES A PRECAUTION STATEMENT: "MONITOR THE PATIENT'S TEMPERATURE AT LEAST EVERY 10 TO 20 MINUTES, AND MONITOR THE PATIENT'S VITAL SIGNS REGULARLY. REDUCE AIR TEMPERATURE THERAPY WHEN THE THERAPEUTIC GOAL IS REACHED OR IF VITAL SIGN INSTABILITY OCCURS. NOTIFY PHYSICIAN IMMEDIATELY OF VITAL SIGN INSTABILITY." THE USER FACILITY DID NOT FOLLOW INSTRUCTIONS AS NOTED IN THE MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657385 ARIZANT BAIR HUGGER (TM) WARMING UNIT WARMING DEVICE DWJ 3M HEALTH CARE 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death 3M BAIR (TM) HUGGER WARMING BLANKET