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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIZANT/3M BAIR HUGGER

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ARIZANT/3M BAIR HUGGER Back to Search Results
Device Problem Contamination (1120)
Patient Problems Bacterial Infection (1735); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/01/2014
Event Type  Injury  
Event Description
This report is submitted regarding injury to (b)(6). On (b)(6) 2014, the bair hugger was used on ms. (b)(6) during the course of right total knee replacement surgery. Because the bair hugger was used, it is believed, contaminants were introduced to her open surgical wound, resulting in an infection. She was required to have three add'l surgeries to remove the implant and clean the infected tissue in her knee. She continues to suffer impaired mobility. Ms. (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. 3m corporation, the mfr of bair hugger faw was notified in writing of the injury by litigation (case (b)(6)) filed in the southern district of (b)(6) on october 12, 2015). Fda guidance dated july 9, 2013 provides that such legal documents constitute a "complaint" requiring the mfr to report to the fda, as follows: "2. 11 where will device-related complaints come from? you have receive complaint info from many different sources, including legal documents. " three m has failed to report this injury within the mandatory 30 days. Ms. (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. From there, 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 (6) studies published in top-tier, 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, ms. (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 NameBAIR HUGGER
Type of DeviceBAIR HUGGER
Manufacturer (Section D)
ARIZANT/3M
MDR Report Key5447801
MDR Text Key38743832
Report NumberMW5060281
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/16/2016 Patient Sequence Number: 1
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