MAUDE Adverse Event Report: 3M COMPANY EDEN PRAIRIE 3M BAIR HUGGER(TM) WARMING UNIT; THERMAL WARMING UNIT

Model Number 505

Device Problem No Apparent Adverse Event (3189)

Patient Problems Burn, Thermal (2530); Superficial (First Degree) Burn (2685)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

Patient id and weight not provided.Product does not have an expiration date.The product manufacturing date and lot number were not provided.E-mail address of reporter not provided.Product was inspected and tested by the hospital and found to be working fine.As noted by the nurse it is possible the warming hose touched the patient due to tension from the drape.Instructions for use does include the following warning: "do not allow the patient to lie on the warming unit hose or allow the hose to directly contact the patient's skin during patient warming; thermal injury may result." end of report.

Event Description

A nurse reported that a (b)(6) female had shoulder surgery in (b)(6) 2015.The patient was warmed with a 3m bair hugger warming unit connected to a gown through the lower hose port.The patient was seated in a beach chair position with a safety strap.It is possible that a blanket was placed between the patient and the warming gown.The patient was noted to have sensitive skin.The surgery lasted a couple of hours.While in recovery the patient was alleged to have a red area about 6 inches in length with an 18 mm blister in the center on the inner thigh.The area was treated with topical silvadene (silver sulfadiazine).The patient was sent home with instructions to apply the silvadene and over-the-counter topical neosporin (bacitracin, neomycin, polymyxin).The patient was seen by her surgeon several times for follow-up.The redness and blister allegedly resolved by early (b)(6) 2016.Additional information received on june 27, 2016- stated the warming unit was set on high for during the procedure.The patient was warmed for 90 minutes during surgery and one hour post-op.During surgery a safety strap was placed over the warming gown on the patient's hips.Surgical drapes were also placed over the warming gown.The warming unit was evaluated and found to be in proper working order.Note: the nurse stated that it was possible that the warming unit hose could have touched the patient's thigh due to tension on the surgical drape.The safety strap was not reported to be over the warming hose.The nurse said that surgical instruments may have been placed on the gown.The warming unit was tested after surgery and found to have no problems.It was functioning as expected and has been used in subsequent surgeries without problems.

• Brand Name: 3M BAIR HUGGER(TM) WARMING UNIT
• Type of Device: THERMAL WARMING UNIT
• Manufacturer (Section D): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 55344
• Manufacturer (Section G): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 5813269
• MDR Text Key: 50135870
• Report Number: 2110898-2016-00074
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505
• Device Catalogue Number: 50500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 3M BAIR PAWS FLEX WARMING GOWN (MODEL 81003)
• Patient Outcome(s): Other
• Patient Age: 57 YR