MAUDE Adverse Event Report: BELMONT INSTRUMENT CORP. THE BELMONT RAPID INFUSER, FMS2000; THERMAL INFUSION FLUID WARMER

Model Number FMS2000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported by the biomed at the hospital, that the belmont rapid infuser, fms2000, exhibited an "over temperature" error message during a liver transplant.The system was replaced and the case was continued.

Manufacturer Narrative

The device was returned for eval.Upon receipt, the fan guards were very dirty and there was a lot of blood on the housing, suggesting the unit was not cleaned after each use as stated in the operator's manual.Otherwise, the unit performed according to our specifications.The system shut down due to over temperature, as it is designed to do: whenever fluid from the heat exchanger reaches our specified limit, the system stops pumping and heating, closes off the line to the pt and instructs the user to restart the system with a new disposable.The volume of tubing between the temperature sensor and the pt is 45 ml so that none of the over temperature fluid can reach the pt.The disposable was discarded by the user and therefore not returned for eval.

• Brand Name: THE BELMONT RAPID INFUSER, FMS2000
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT CORP.; 780 boston rd.; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston rd.; billerica, MA 01821 ; 9786630212
• MDR Report Key: 3750252
• MDR Text Key: 4480571
• Report Number: 1219702-2014-00001
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FMS2000
• Device Catalogue Number: 903-00001
• Other Device ID Number: 10896128002012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1