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

Model Number RI-2

Device Problem Mechanical Problem (1384)

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

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

The hospital biomed was unable to duplicate the complaint in the lab and the rapid infuser was subsequently returned to belmont for investigation.The device was tested using our standard operating procedures, and we were also unable to confirm the customer complaint that the valve motor intermittently was not functioning; the unit performed according to our specifications upon receipt.After every 500ml of fluid infused, the rapid infuser automatically purges air from the system by closing the infusion line and opening the recirculation line for a few seconds.In the event of a valve failure or valve position sensor malfunction, the system exhibits a "valve fault" alarm (system error #208) and displays the following alarm message: "check valve for blockage.Power off and restart.Service machine if error persists." the operator's manual also provides a service and preventive maintenance schedule, which instructs the user to perform a visual inspection every 6 months, including checking that the valve pincher set screw is tight.In addition, the manual also instructs the user to perform a hardware verification once a year and provides the following instructions: "press left valve, confirm that the valve wand (valve pincher) moves to the left.Press open valve, confirm that valve wand moves to the middle position.Press right valve, confirm that the valve wand moves to the right.Leave the valve in the left valve position before continuing to the next step." the manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that there was no injury to the patient.We will continue to monitor and trend similar reports of this nature.

Event Description

The hospital biomed reported the following, involving a belmont rapid infuser, ri-2: "there was a report of the valve motor not functioning intermittently during a case." the biomed was unable to confirm the complaint in the lab, but agreed to send the unit back for investigation.There was no harm to the patient.

• 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: 8977028
• MDR Text Key: 197951427
• Report Number: 1219702-2019-00060
• Device Sequence Number: 1
• Product Code: LGZ
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/07/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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