MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ BAIR HUGGER¿ WARMING UNIT; HYPER/HYPOTHERMA SYSTEM

Model Number 675

Device Problems Fire (1245); Smoking (1585); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Patient specifics are unknown it is unknown if the reporter is a health professional - manufacturer location: country: usa.Product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the exact root cause of the alleged injury or whether the 3m¿ bair hugger¿ warming unit was the root cause.The 3m bair hugger¿ temperature management unit model 675 service manual states the following: contraindication: to reduce the risk of thermal injury: do not apply heat to lower extremities during aortic cross-clamping.Thermal injury may occur if heat is applied to ischemic limbs.Warning: to reduce the risk of thermal injury: the bair hugger warming unit model 675 has been designed to operate safely only with 3m disposable warming blankets and gowns.Use with other products may cause thermal injury.To the full extent permitted by law, the manufacturer and/or importer declines all responsibility for thermal injury resulting from the warming unit being used in conjunction with non-3m warming blankets and gowns.(see www.Bairhugger.Com for list of 3m disposable warming blankets and gowns) do not treat patients with the bair hugger warming unit hose alone.Always attach the hose to a 3m warming blanket/gown before providing warming therapy.Do not place the non-perforated side of the warming blanket/gown on the patient.Always place the perforated side (with the small holes) directly on top of the patient in contact with the patient's skin.Do not place the warming blanket/gown directly over a dispersive electrode pad.For the bair hugger flex warming gown; ensure that the blood pressure cuff, ecg, iv or other lines or cords are not between the upper sleeve insert and the gown prior to deploying the upper sleeve warming insert(s), as this could result in tearing of the insert during deployment.For over-body warming blankets and gowns; do not place patient securement device (i.E.Safety strap or tape) over the warming blanket/gown.For underbody or side channel warming blankets; if a securement device (i.E.Safety strap, tape) is used, ensure the warming channels are not occluded.· do not allow the patient to lie on the warming unit hose.Do not allow the warming unit hose to directly contact the patient's skin during warming therapy.Do not connect a torn or damaged warming blanket/gown to the warming unit.Do not leave patients with poor perfusion unmonitored during prolonged warming therapy.Do not leave neonates, infants, children, and other vulnerable patient populations unattended during warming therapy.Do not continue warming therapy if the red over-temp symbol illuminates and the alarm sounds.Unplug the warming unit and contact a qualified service technician.Do not perform the over-temperature detection system test while the warming unit is being used for warming therapy caution: to reduce the risk of fire: 3m warming blankets and gowns are classified as class i normal flammability as defined by the consumer product safety commissions flammable fabric regulation, 16 cfr 1610.Follow standard safety protocols when using high intensity heat sources.Caution: to reduce the risk of thermal injury, hyperthermia or hypothermia: 3m recommends continuously monitoring core temperature.In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.Monitor cutaneous responses of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.Adjust air temperature or discontinue therapy when the therapeutic goal is reached, if elevated temperatures are recorded or if there is an adverse cutaneous response in the warmed area.

Event Description

A children's hospital alleged an electrical fire with sparking, smoking, and melting with the use of the 3m¿ bair hugger¿ warming unit, model 675.No injuries and no medical intervention were reported.

• Brand Name: 3M¿ BAIR HUGGER¿ WARMING UNIT
• Type of Device: HYPER/HYPOTHERMA SYSTEM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 53344
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 16648262
• MDR Text Key: 312370311
• Report Number: 2110898-2023-00035
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00707387803940
• UDI-Public: 00707387803940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 675
• Device Catalogue Number: 67500
• Device Lot Number: 23852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1