MAUDE Adverse Event Report: KIMBERLY CLARK/HALYARD HEALTH INC./NORTECH SYSTEMS, INC. KC M1000 (MADE BY HALYARD) WARMING SYSTEM; SYSTEM, THERMAL REGULATING

Model Number M1000

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/18/2022

Event Type  Injury  

Event Description

We used kc m1000 made by halyard intraoperative warning system in 2 cardiac surgery pts and both had second degree burns on their back which prolonged their hospital stay and required wound care at home.This system uses gel pads that get applied to pt's back and water runs through the pads to provide heat to keep the pt warm during surgery.This system is used in many hospitals across the usa and internationally.We stopped using the device after those 2 incidents.(b)(4) (pt safety investigation) done.Incident disclosed to the pts.Kc company was informed of the incidents and the decision to stop using their product.The 2 pts were having cardiac surgery with cardio-pulmonary bypass.

• Brand Name: KC M1000 (MADE BY HALYARD) WARMING SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): KIMBERLY CLARK/HALYARD HEALTH INC./NORTECH SYSTEMS, INC.
• MDR Report Key: 15055195
• MDR Text Key: 296254233
• Report Number: MW5110947
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1000
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Male