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

Catalog Number 403-00406

Device Problems Overheating of Device (1437); Smoking (1585); Material Deformation (2976); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 05/31/2022

Event Type  Death  

Event Description

During a case on (b)(6) 2022, the user started noticing smoke coming out of the front door but there was no alarm or error code presented.The disposable set was deformed from excessive heat.Another ri-2 was brought in to finish the case.The patient was not harmed.Update on (b)(6) 2022 from the user.While infusing blood products at a rate of 200 ml/min to 650 ml/min, everyone in the room started to notice the smell of an electrical fire.Multiple staffs in the room were looking for the source of the smell, when a cst (certified surgical technologist) noticed that there was smoke coming from the main door of the rapid infuser.The device was turned off.When biomed opened the door, a plume of smoke came out and it was noticed that the top 1/3 of the heat exchanger was visibly burnt/melted.No alarms were heard, nor did the device indicate overheated blood being pumped to the patient.The unit was changed out and the damaged disposable was bagged and submitted to biomed for examination and will be returned to belmont for investigation.

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 on 06/15/2022.During a case on (b)(6) 2022, the user started noticing smoke coming out of the front door but there was no alarm or error code presented.The disposable set was deformed from excessive heat.Another ri-2 was brought in to finish the case.The patient was not harmed.Belmont received an update on (b)(6) 2022 from the user: while infusing blood products at a rate of 200 ml/min to 650 ml/min, everyone in the room started to notice the smell of an electrical fire.Multiple staffs in the room were looking for the source of the smell, when a cst (certified surgical technologist) noticed that there was smoke coming from the main door of the rapid infuser.The device was turned off.When biomed opened the door, a plume of smoke came out and it was noticed that the top 1/3 of the heat exchanger was visibly burnt/melted.No alarms were heard, nor did the device indicate overheated blood being pumped to the patient.The unit was changed out and the damaged disposable was bagged and submitted to biomed for examination and will be returned to belmont for investigation.Patient death was noted but not attributed to the device.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 exhibits 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.The operator's manual provides the following warning statement: "do not infuse blood that is in the disposable set when over temperature condition occurs.Red cells that have been subjected to high temperature may not be safe to infuse".Although there is no information available on use of contraindicated fluids 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.Belmont is currently investigating the returned device.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.

Manufacturer Narrative

Upon receipt of the referenced rapid infuser, ri-2 unit s/n: (b)(6), 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 heater control board, the power drive module assembly, and all cables in the system for proper connections, and they were all connected and operated properly.However, it was noticed that the plastic cover at the door was cracked.Otherwise, the system performed according to our specifications upon receipt.No device malfunction could be verified and the root cause could not be determined.Belmont service department replaced the plastic cover at the door assembly and 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.Although there is no information available on use of contraindicated fluids 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.The operator's manual also provides possible conditions and additional recommended operator actions.In order to ensure that the belmont's device is used as intended by the user facility, an educational on-site training will be performed on august 31st, 2022 by the belmont's clinical specialist.An additional follow-up report will be submitted once the training is completed and or additional information becomes available.

Manufacturer Narrative

Evaluation: the disposable was also received back for investigation and the reported deformation of the heat exchanger was confirmed.Investigation verifies that the heat exchanger is deformed/melted due to excessive heat.There is no evidence of any manufacturing defects.No lot number was provided for the reported 3-spike disposable; therefore, a thorough investigation into the specific lot of 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.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.Belmont's clinical specialist, (b)(6) visited the user facility in order to conduct a re-training on correct use of the device and avoid any such similar incident in future.The training was conducted on sept 26th and 28th which included all the clinical staff and it was ensured that they are well aware of the compatible fluids and appropriate usage of the device as per belmont's specifications.

• 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: 14957313
• MDR Text Key: 295497885
• Report Number: 1219702-2022-00028
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 403-00406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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