MAUDE Adverse Event Report: 3M BAIR HUGGER

Model Number 775

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)

Event Date 11/07/2016

Event Type  Injury  

Event Description

Child developed a large 14cm x 9cm reddened area to left flank/back that on post-op day 2 started blistering/sloughing, consistent with a burn injury.(b)(6) old male with ingestion of foreign bodies taken to operating room for an exploratory laparotomy with partial small bowel resection with closure of enterotomy.A pediatric underbody bair hugger that was used during the case.Anesthesia start time of 0223 and end time of 0504.The device was utilized upon initiation of the case and use was discontinued at 0355 as the pt's temperature was 37.8 and no longer required this device.Upon completion of the case and transfer to the pacu, the child was noted to have a 14cm x 9cm reddened area to left flank/back that was not noted to be present prior to the case.Throughout the morning, the area became darker and appeared tender.On post-op day 2, the wound began to blister and slough skin, consistent with a burn.Upon further investigation, the device was utilized as per the mfr's recommendations.There were no alarms received by the device indicating the device temperature was too high.The device was removed from service and our biomed department evaluated the equipment and found no issues.All bair hugger devices at this facility have recently been upgraded and of note 3 of our other bair hugger devices have been alarming high temperature and have also been removed from service.The concerns have been reported to the mfr and they are currently investigating.

• Brand Name: BAIR HUGGER
• Type of Device: BAIR HUGGER
• Manufacturer (Section D): 3M
• MDR Report Key: 6112629
• MDR Text Key: 60565851
• Report Number: MW5066097
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 775
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BACITRACIN OINTMENT TWICE A DAY; HYDROPHOR OINTMENT 3/DAY FOR TREATMENT OF BURN; IBUPROFEN/TYLENOL
• Patient Outcome(s): Other
• Patient Age: 18 MO
• Patient Weight: 13