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

Model Number RI-2

Device Problems Electrical /Electronic Property Problem (1198); Electrical Overstress (2924)

Patient Problem Ruptured Aneurysm (4436)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the rapid infuser, ri-2 was being used to deliver fluid during an urgent surgery for a ruptured aortic aneurysm when power cut off to the theatre.The ri-2 reportedly tripped 50% of the circuits in the or but continued to run on battery (as designed when the ri-2 is disconnected from an ac power source).The users subsequently plugged the ri-2 into a different circuit which tripped the remainder of the or.Follow up with the user facility revealed that the unit was being used in the or on a pendant system, which is not in accordance with the instructions for use.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." belmont instructs that the ri-2 system be used on a dedicated line, as the system can draw a significant fraction of the circuit capabilities and therefore cause the theatre breakers to trip when the line is shared.It was reported that the ri-2 was being used to deliver fluid during an urgent surgery for a ruptured aortic aneurysm.There is no evidence to suggest that the failure directly contributed to the patient death.Belmont has conducted a review of similar complaints for the past three years and has determined that this was an isolated incident.The ri-2 involved was initially quarantined by the hospital and was held subject to an investigation.The unit was subsequently released and was received by belmont on (b)(6) 2021.The unit is currently undergoing a full evaluation.The ri-2 unit reportedly involved in the event is a loaner unit provided to the hospital by belmont.Belmont has conducted a review of the manufacturing and service records for this serial number; no anomalies were identified.A review of the preventive maintenance records indicates that the device was maintained in accordance with the preventive maintenance schedule provided in the instructions for use.A follow-up report will be submitted upon completion of the investigation.

Event Description

Belmont medical technologies received a report that a patient undergoing a vascular treatment at (b)(6) hospital in (b)(6) was involved in an equipment issue on (b)(6) 2021.The report stated the following: "belmont rapid infuser being used to deliver fluid during urgent surgery for ruptured aortic aneurysm.Power cut off to entire theatre and traced to the fluid warmer.Unable to discontinue fluid delivery due to deteriorating patient and estates department initially called to hold circuit breaker on, however patient died on table.".

Manufacturer Narrative

It was reported that the rapid infuser, ri-2 was being used to deliver fluid during an urgent surgery for a ruptured aortic aneurysm when power cut off to the theatre.The ri-2 reportedly tripped 50% of the circuits in the or but continued to run on battery (as designed when the ri-2 is disconnected from an ac power source).The users subsequently plugged the ri-2 into a different circuit which tripped the remainder of the or.The director of belmont medical technologies in the uk visited the site on 7/27/2021 to observe evaluation of the system.Investigation revealed that the unit was being used in the or on a pendant system and plugged into the normal circuit for the floor cleaners when the or systems tripped.This is not in accordance with the instructions for use.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." when the unit was evaluated on site at the hospital, the ri-2 system tripped, as well as the 30amp main in medical physics.The unit was opened and the power driver module was removed, revealing significant burn damage to the components on the board as a result of the electrical trip.The unit was subsequently released and returned to belmont's manufacturing headquarters in the us on 8/4/2021, and has undergone a full evaluation.Belmont's investigation of the device revealed that four power transistors on the driver a board were shorted and damaged, which caused the system's internal circuit breaker to trip.Due to the significant burn damage to the components on the board, it is not possible to establish a definitive root cause of the initial failure/shorted transistors.The conclusion reached is that this incident occurred due to a failure to follow the instructions provided in the operator's manual regarding ac input voltage and ac receptacle requirements for use of the ri-2 device.Belmont instructs that the ri-2 system be used on a dedicated line, as the system can draw a significant fraction of the circuit capabilities and can therefore cause the circuits to trip when the line is shared.Belmont has conducted a review of similar complaints for the past three years and has determined that the incidence rate is extremely low.The ri-2 unit reportedly involved in the event is a loaner unit provided to the hospital by belmont.Belmont has conducted a review of the manufacturing and service records for this serial number; no anomalies were identified.A review of the preventive maintenance records indicates that the device was maintained in accordance with the preventive maintenance schedule provided in the instructions for use.There is no allegation that the device directly contributed to the patient death.Belmont has conducted a review of similar complaints for the past three years and has determined that this was an isolated incident.

• 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: 12317014
• MDR Text Key: 267457606
• Report Number: 1219702-2021-00114
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002817
• UDI-Public: (01)00896128002817
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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: 903-00039A-UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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