MAUDE Adverse Event Report: BREG, INC. BREG; PACK, HOT OR COLD, WATER CIRCULATING

Model Number POLAR CARE CUBE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  malfunction  

Event Description

Patient status post right knee arthroscopic surgery came to recovery room with a breg polar care cube.Cna filled the machine with ice and water and attached the tubing to the cooling pad which was already on the patient's right knee (under a brace).When the patient's mother arrived to the bed she mentioned there was water on the floor.I went around to that side of the bed and noticed that in addition to there being water on the floor, the bedding was wet and the patient's dressing was saturated with cold water.I inspected the tubing and could see water was leaking at the connection site of the tubing between the machine and the cooling pad.The tubing appeared to be connected properly.Doctor was contacted and his pa was sent to take down and replace the patient's wet dressing.

• Brand Name: BREG
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave e; carlsbad CA 92010
• MDR Report Key: 11684624
• MDR Text Key: 246015811
• Report Number: 11684624
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: POLAR CARE CUBE
• Device Catalogue Number: 10701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5475 DA
• Patient Weight: 104