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 No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

Our hospital has noticed a trend in ice/water containers leaking during post-surgical orthopedic surgery.No harm to any patients but over the past month or so we've see approximately 9 ice coolers and/ or their connected pads leaking.We have been sending the ice boxes and pads back to the manufacturer for replacements and we came to understand the consistent need to replace so many we felt it time to look at the issue.Most ice cooler boxes and the related connecting pads are not fully identified as far as lot numbers; however, we felt we needed to move forward with at least 1 lot number of a known-device.Again, no patient harm but just aspect of the devices consistently leaking.

• Brand Name: BREG
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• MDR Report Key: 8499835
• MDR Text Key: 141478763
• Report Number: 8499835
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736017647
• UDI-Public: (01)00672736017647
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: POLAR CARE CUBE
• Device Catalogue Number: 10701
• Device Lot Number: 292368283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1