MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER, RI-2; THERMAL INFUSION FLUID WARMER

Catalog Number 403-00411

Device Problems Overheating of Device (1437); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2022

Event Type  Death  

Manufacturer Narrative

The internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident was returned to belmont medical technologies for evaluation.However, disposable set was not sent back for review.It was reported by the biomed that he would like to send the unit back to belmont for evaluation due to an overheating issue.On (b)(6) 2022, belmont sent an email request asking for more details of the incident.Clinician was using the ri-2 during trauma on 02/24/2022 and an overheat alarm was triggered.On (b)(6) belmont became aware that the patient expired.Belmont's territory manager and regional sales manager visited the facility to investigate the event further.The belmont's clinical specialist was unable to determine the cause of the incident from ther visit.However, they suspect that lr (lactated ringers) was accidentally used instead of ns (normal saline), but this can't be confirmed.When the rapid infuser detects a situation that is compromising 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 an "over temperature" alarm, the rapid infuser displays the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.There is no information available about the fluids used during the procedure.Certain infusates are contraindicated and may lead to clot formation inside the heat exchanger, which can block blood flow and result in an "over temperature" alarm.Evaluation: upon receipt of the referenced rapid infuser, ri-2 unit s/n: (b)(4), the service engineers unable to confirm the customer complaint after extensive testing and 48 hours of stress testing at elevated temperatures.They also double checked both input and output temperature probes, the power drive module, and all cables in the system for proper connections, and they were all connected and operated properly.The unit performed according to our specifications upon receipt.The 3-spike disposable set was not returned to belmont for evaluation and lot number was not available; therefore, a thorough investigation into the disposable set is not possible.All 3-spike sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.No device malfunction could be verified and the root cause could not be determined.Belmont service department upgraded the system to the current revision and operated the unit at elevated temperature for 48 hours.Upon completion, a final functional test, an electrical safety test, and a final inspection were performed.The unit passed all test specifications and inspection requirements.Additionally, the manufacturing records for this serial number were reviewed and no anomalies or similar trend in complaints were identified.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

Event Description

2/24 clinician was using device during trauma and overheat alarm was triggered.5/20 - additional information obtained stating the patient expired during the event.No indication that the device contributed to the patient death.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 14742705
• MDR Text Key: 294375290
• Report Number: 1219702-2022-00025
• 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: User Facility
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 403-00411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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