MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION KIMBERLY-CLARK PATIENT WARMING SYSTEM; SYSTEM, THERMAL REGULATING

Model Number M1000-01

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

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

Event Date 06/09/2022

Event Type  malfunction  

Event Description

Patient in cardiovascular operating room for heart surgery.Due to the long surgery (5 hours), a patient warming system was used.The halyard thermal pad was connected to a kimberly-clark patient warming system via a hose, and the pad lain flat on the or table.Two draw sheets were placed over the warming pad, and then the patient lay on top of that, on her back.A sterile antiseptic solution was applied chin to knees; with towels on the flanks to keep the prep from dripping down to the table.After surgery, patient was found to have a 3-4 inch diameter blister to the left side of her middle back.Unfortunately, staff discarded the disposable warming pad.The machine was evaluated by our biomed department and passed all tests, and was up to date on preventative maintenance.It is unclear exactly what caused the burn.

• Brand Name: KIMBERLY-CLARK PATIENT WARMING SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; 1400 holcomb bridge rd; roswell GA 30076
• MDR Report Key: 16511909
• MDR Text Key: 310969387
• Report Number: 16511909
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M1000-01
• Device Lot Number: 4168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White