MAUDE Adverse Event Report: 3M BAIR HUGGER; THERMAL REGULATORY SYSTEM

Device Problems Product Quality Problem (1506); Microbial Contamination of Device (2303)

Patient Problems Anemia (1706); Hematoma (1884); Post Operative Wound Infection (2446); Blood Loss (2597)

Event Date 10/16/2012

Event Type  Injury  

Event Description

This report concerns injury to (b)(6).On or about (b)(6 2012, mr.(b)(6) underwent surgery during which bair hugger was used at the (b)(6) by dr.(b)(6).It is believed that the use of bair hugger resulted in a periprosthetic joint infection.He has undergone multi-staged removal and revision arthroplasties, antibiotic therapy, and suffered additional complications from revision surgeries such as post-operative acute blood loss, anemia, and post-operative hematoma requiring additional hospitalization and treatment, and plaintiff was ultimately discharged to a rehabilitation facility for recovery.Approximately six procedures were done on or about (b)(6) 2013, at (b)(6) hospital; (b)(6)hospital, (b)(6); and (b)(6) center; by dr.(b)(6).Mr (b)(6) believes that the infection was caused by contamination of the surgical field by the waste heat of the bair hugger forced-air warming system ("faw") used during his surgery.The 3m corporation, the mfr of bair hugger faw was notified of the injury by litigation (case (b)(6)).The 3m has failed to report this injury within the mandatory 30 days.Mr (b)(6) believes that the approx 1000 watts of waste heat from bair hugger escapes from below the surgical drapes near the floor.It warms the contaminated air resident near the floor and forms into convection currents of rising contaminated warm air.The warm air rises alongside the surgical table, penetrating operating room ventilation airflow and ending up in the surgical field.A (b)(6) committee considering heater-cooler devices recently warned that "nothing that blows air should be in an operating theater, if possible" and "it is important not to blow air in the operating theater." nine studies published in peer-reviewed medical journals confirmed the contamination.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 conclusion that the waste heat from bair hugger must be increasing the risk of pji.One large outcome study has positively linked this rising waste heat to the majority of pjis after total joint replacement surgery.There are no studies showing that bair hugger is safe in implant surgery.Mr (b)(6) also asserts that 3m has 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 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 peer-reviewed medical journals.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, no product that increases the risk of a pji should be allowed in orthopedic surgery.

• Brand Name: BAIR HUGGER
• Type of Device: THERMAL REGULATORY SYSTEM
• Manufacturer (Section D): 3M
• MDR Report Key: 6033370
• MDR Text Key: 57650274
• Report Number: MW5065429
• 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: Unknown
• Type of Report: Initial
• Report Date: 10/13/2016

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?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability