MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION BELMONT; WARMER, THERMAL, INFUSION FLUID

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 10/06/2015

Event Type  malfunction  

Event Description

The staff noticed a leak while blood was infusing through the belmont tubing.Blood was observed to be on the bottom of the fluid warmer.The staff changed out the tubing to another belmont tubing set and blood was also observed to be leaking.In addition, blood was again seen in the bottom of the warmer.Upon closer examination, the staff noticed what appeared to be a crack located on the top of the warming component inside the center of the fluid warmer.

• Brand Name: BELMONT
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston road; billerica MA 01821
• MDR Report Key: 5187476
• MDR Text Key: 29808489
• Report Number: 5187476
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Other Device ID Number: TUBING SET LOT NUMBER 2014-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR