MAUDE Adverse Event Report: ARIZANT / 3M BAIR HUGGER

Device Problems Nonstandard Device (1420); Contamination /Decontamination Problem (2895)

Patient Problems Unspecified Infection (1930); Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is submitted regarding injury to (b)(6).Ms.(b)(6) had a left total knee replacement during which, it is believed, a bair hugger forced air warming blanket was used.Ms.(b)(6) experienced persistent pain and symptoms related to a deep infection in her knee.She was forced to undergo an irrigation and debridement of her left knee with a revision of the knee component on (b)(6) 2014.Following this surgery, she underwent further treatment, including iv antibiotics and left knee resection with placement of an antibiotic spacer on or about (b)(6) 2014 and other surgeries stretching into 2015.The infection, it is believed, occurred because the bair hugger was used, causing contaminants to be introduced to ms.(b)(6) open surgical wound.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.The 3m corporation, the mfr of bair hugger, was notified in writing of the injury by litigation (case (b)(6)).Fda guidance dated 07/09/2013 provides that such legal documents constitute a "complaint" requiring the mfr to report to the fda,.The manufacturer, 3m, 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 pjis 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 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 pjis, 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.

• Brand Name: BAIR HUGGER
• Type of Device: BAIR HUGGER
• Manufacturer (Section D): ARIZANT / 3M
• MDR Report Key: 5624459
• MDR Text Key: 44210883
• Report Number: MW5062021
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability