MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number RI-2

Device Problems No Display/Image (1183); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation and was tested using our standard operating procedures.We were unable to confirm the customer complaint of a burning odor.However, we were able to confirm that the unit powered up with a blank display.Upon receipt, it was noted that the display was damaged due to saline contamination.As fluid contamination may damage internal components, the service and preventive maintenance schedule outlined in the operator's manual instructs the user to check the unit seals every six months.The following instructions are provided: "inspect the seal around the unit to make certain it is in good condition.Check also the seal around the touch screen and ceramic disks.Use dow corning 732 multipurpose rtv sealant or equivalent if needed to maintain fluid resistance." we were unable to investigate the disposable set, as it was not returned for evaluation.Without further information, it is difficult to determine whether the device was the cause of the burning odor.There was no patient injury reported.Should additional information become available, a supplemental report will be submitted accordingly.

Event Description

The belmont sales representative received a complaint from the user facility and relayed the following report: "a call from (b)(6), operating room materials manager, who reported that during a case earlier today, during use, the anesthesia staff smelled a strong burning odor.When the unit was taken from the or to biomed for review, the burning odor was gone, but the screen was blank, even after reboot of the system.The screen apparently was still active as touching the screen still activated the pump, but the visual aspect was not working.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 8502252
• MDR Text Key: 151919718
• Report Number: 1219702-2019-00020
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00037
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1