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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation on (b)(6) 2021 ; evaluation of the unit is in process.When the rapid infuser, ri-2 detects a situation that may compromise effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.In the event of a "valve fault" alarm (system error 208), the ri-2 system immediately closes the infusion line to the patient and instructs the user: "check valve for blockage.Power off and restart.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.A service and preventive maintenance schedule is provided in the manual, which instructs the user to perform a visual inspection every 6 months, including checking that the valve pincher set screw is tight.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 no anomalies were identified.It was reported that there was no injury to the patient.A follow-up report will be submitted upon completion of the investigation.

Event Description

The user facility reported that the belmont rapid infuser, ri-2 experienced a "system error 208" during a case.The hospital biomed noted that the one of the mounting screws on the valve motor was sheared off and the rest were loose.

• 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: 11868598
• MDR Text Key: 252699117
• Report Number: 1219702-2021-00072
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/23/2021

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?: Yes
• 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: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2018
• 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