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

Catalog Number 403-00107

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

The biomed reported that the users were unable to turn on power to the unit.The patient had gun shot wounds and passed away in the operating room after being transferred from emergency room.On april 5th, the biomed informed belmont that after investigating the issue it was found that the battery was bad.After the battery was replaced, the unit worked as intended.Therefore, they will not be sending device back to belmont for investigation.Although the patient involved in the incident expired, on further follow-up, the biomed confirmed on april 18th that the device did not cause or contributed to death.

Manufacturer Narrative

The internal complaint file #cmp (b)(4).Have been logged for this incident for traceability.The device involved in the incident will not be returned to belmont for investigation since it was identified as end of life.The biomed reported that the users were unable to turn on power to the unit.The patient had gun shot wounds and passed away in the or after being transferred from er.On april 5th, the biomed informed belmont that after investigation the issue was determined to be that the battery was bad.After the battery was replaced by the biomed, the unit worked as intended.Therefore, they will not be sending device back to belmont for investigation.Although the patient involved in the incident expired, on further follow-up, the biomed confirmed on april 18th that the device did not cause or contributed to death.After reviewing the serial number, we found out that the device was end of life.In the event of:"low battery", the system will display "batt low" message and sound an audible alarm.The system should be plugged into an ac outlet to continue operation and charge the battery.The operator action as,"if low battery displayed while the system is connected to ac power, one of the components may be defective.Service machine.If battery is completely discharged, turn the ac power off, plug the system into an ac outlet to recharge the battery.Wait for at least 30 seconds before turning the system on ".Belmont is working with this hospital to replace the end of life devices.Additionally, there is a possibility of user error in this incident, belmont's clinical specialist will be visiting the user facility on may 22nd to train the hospital staff for refresher training on the device and gather additional details on the event.A follow-up report will be submitted once the training is complete and additional information becomes available.

Manufacturer Narrative

The device involved in the incident was not returned to belmont for investigation since it was identified as end of life.The cited device was requested to investigate the reported issue, however the customer provided additional information that the issue was isolated to the battery and replacing the battery resolved the issue.The device and battery were both not available for further investigation.This device has reached end of life and was traded in for a new rapid infuser.The customer was provided an end-of-life letter prior to the reported issue.The device history was reviewed, and no similar issues were identified.Belmont clinical specialist will be conducting in-service with the customer to train the hospital staff for refresher training to demonstrate the proper use of device per our specifications and ensure that they are comfortable utilizing the replaced rapid infuser.We also provided them with the most up to date quick reference guide that details set up and lists compatible fluids.No device malfunction could be verified, and the root cause could not be determined.Belmont will continue to monitor this issue moving forward.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Type of Device: PUMP INFUSION
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica
• 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: 16836156
• MDR Text Key: 314539052
• Report Number: 1219702-2023-00021
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 403-00107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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