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

Model Number RI-2

Device Problem Power Problem (3010)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The belmont rapid infuser, ri-2 has been returned to belmont for investigation; evaluation of the unit is in process.This report is for serial number (b)(4); a separate report will be entered for serial number (b)(4).There is insufficient information available at this time to establish a root cause of the reported circuit breaker tripping.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adapter for ungrounded outlets." the manufacturing records for this serial number were reviewed and no anomalies were identified.No patient injury was reported.A follow-up report will be submitted upon completion of the investigation.

Event Description

The hospital biomed relayed the following report from the physician involving a rapid infuser, ri-2: "today in one of our cardiac rooms, we were infusing just normal saline at a rate of reported 2.5ml/min.While in use the belmont tripped the wall breaker, and tripped the internal breaker in the device itself.After several attempts of swapping power supply sources and trying to turn the device back on, both breakers continued to snap off.When i turned the device on without plugging the belmont into a wall power supply, the unit would stay on and not flip its internal breaker." the reported incident involved two ri-2 units.This report is for serial number (b)(4); a separate report will be entered for serial number (b)(4).

Manufacturer Narrative

The belmont rapid infuser, ri-2 was returned to belmont for investigation.Upon receipt, it was identified that several transistors and optocouplers on driver a/b boards were shorted and damaged.This caused the internal system circuit breaker to trip as reported, however belmont was unable to confirm the report that the system tripped the wall breaker.Root cause of the damaged components could not be established.The operator's manual provides ac input voltage requirements and instructs the user, "plug the system power cord into a dedicated-grounded, 3-prong, 20 amp, ac receptacle.Do not use an adapter for ungrounded outlets.Ensure that circuit breaker is easily accessible to turn off in an emergency situation." the manufacturing records for this serial number were reviewed and no anomalies were identified.No patient injury was reported.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.

• 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: 12290949
• MDR Text Key: 265579650
• Report Number: 1219702-2021-00105
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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