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

Model Number RI-2

Device Problems No Visual Prompts/Feedback (4021); No Tactile Prompts/Feedback (4024)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 was returned to belmont for investigation and underwent testing according to our standard operating procedures, as well as stress testing at elevated temperatures for 48 hours.We were unable to duplicate the customer complaint that the touch screen was frozen.The functionality of the display, membrane switch, gathering board, and cpu board were verified, and all cables in the system were checked for proper connections; the unit performed according to specification and passed all inspection requirements.Fluid contamination can cause problems with the membrane switch which may resolve once the fluid has dried, however belmont has replaced the display, membrane switch, and gathering board as a precaution.The operator's manual cautions the user: "immediately wipe any spills from the device." the service and preventive maintenance schedule outlined in the manual also instructs the user to check the unit seals every six months.Without the ability to reproduce the reported problem, a root cause cannot be established.The manufacturing records for this serial number were reviewed and no anomalies were identified.It was reported that there ws no injury to the patient.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.

Event Description

On march 11, 2021, belmont received a report from the biomed at the user facility that 15 minutes into a trauma case with the belmont rapid infuser, ri-2, the touch screen became frozen and unresponsive.Belmont subsequently received a medwatch report (uf/importer report # (b)(4)) from the department of health & human services, detailing the incident: "while using a rapid infuser unit for a massive transfusion protocol patient, the unit's touchscreen quit working and would not respond to touch.The blood infusion rate went to 0, but the blood products were still infusing.No injury to the patient.The unit was immediately pulled from service and sent to biomedical engineering.Biomedical engineering follow up: the unit display was frozen and reading zero.Confirmed no touch screen response.Pump was working o.K.Because this unit is still under warranty, we will return it to the manufacturer for inspection.".

• 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: 11646622
• MDR Text Key: 267826702
• Report Number: 1219702-2021-00051
• 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: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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