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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M BAIR HUGGER/3M

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3M BAIR HUGGER/3M Back to Search Results
Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)
Patient Problems Injury (2348); Post Operative Wound Infection (2446); Limited Mobility Of The Implanted Joint (2671)
Event Date 04/29/2013
Event Type  Injury  
Event Description
This report concerns injury to (b)(6).On or about (b)(6) 2013, bair hugger was used on (b)(6) during right hip replacement surgery.It is believed that contaminants introduced into his open surgical wound by bair hugger resulted in a periprosthetic joint infection.She needed additional surgical procedures to remove the implant and clean the infected area and continues to suffer impaired mobility, which generally requires her to use a cane when walking.(b)(6), her experts, and lawyers believe that the infection was caused by contamination of the sterile surgical field by the waste heat of the bair hugger forced-air warming system ("faw") used during her surgery.The 3m corporation, the mfr of bair hugger faw was notified in writing of the injury by litigation (case (b)(6)).Fda guidance dated july 9, 2013 provides that such legal documents constitute a "complaint" requiring the mfr to report to the fda.The manufacturer 3m, has failed to report this injury within the mandatory 30 days.(b)(6) and her lawyers assert that the approx 1000 watts of waste heat from bair hugger faw escapes from below the surgical drapes near the floor.It warms the contaminated air normally resident near the floor and forms into convection currents of rising contaminated warm air.The warm air rises alongside the surgical table, easily penetrating operating room ventilation airflow and ending up in the sterile surgical field.This phenomenon has been proved in at least six studies published in peer-reviewed medical journals.Many other studies have shown that the concentration of airborne contaminants above the wound positively correlates with the concentration of contaminants in the wound, and also positively correlates with the periprosthetic joint infection ("pji") rate.This leads to the inevitable conclusion that the waste heat from bair hugger faw must be increasing the risk of pji.At least one large outcome study has positively linked this rising waste faw heat to the majority of pji's after total joint replacement surgery.In contrast, there are no outcome studies showing that bair hugger faw is safe in implant surgery.In a separate issue, (b)(6) asserts that 3m has willfully violated the terms of the bair hugger 510 (k).When 510 (k) #12345676 was filed in 2004, the mfr committed to a "hepa" quality inlet filter (99.97% or greater filtration efficiency).In fact, the inlet filter of the bair hugger model 505 blower was never hepa and has now been reduced to 62% efficiency without notifying the fda.The result of the poor inlet filtration is that the internal airflow pathways of nearly all bair hugger blowers and hoses are contaminated with growing bacterial colonies.This has been shown in three studies published in top-tier, peer-reviewed medical journals.Further, the high-velocity airflow over the bacterial colonies has been shown to aerosolize bacteria out of the hose and into the operating room air.Since it is impossible to disinfect the internal airflow pathway of the bair hugger 505 blower, a hepa filter should be added to the outlet hose of these blowers to prevent the contamination of the operating room with the bacteria growing inside the blower and hose.Given the catastrophic nature of pji's, it is only prudent for the fda to err on the side of caution.Considering that there are several air-free and waste heat-free pt warming devices on the market today, any product that increases the risk of a pji should not be allowed in orthopedic surgery.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key5907098
MDR Text Key53274711
Report NumberMW5064367
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation No Information
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;