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

Model Number	RI-2
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation on (b)(6) 2021; evaluation of the unit is in process.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 exhcanger, which can block blood flow and result in an "over temperature" alarm.The manufacturing records for this serial number were reviewed and no anomalies were identified.The associated disposable set was discarded at the hospital and no lot number was available, therefore review of a specific library/retain sample and batch record information is not possible.Without results of the investigation, it is difficult to draw a conclusion regarding the "over temperature" alarm and damage to the disposable set.No patient injury was reported.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported that the rapid infuser, ri-2 exhibited an "over temperature" alarm 45 minutes into a case.The disposable set was damaged from excessive heat.
Additional Manufacturer Narrative
The rapid infuser, ri-2 was returned to belmont for investigation.The report of an "over temperature" alarm could not be confirmed after extensive testing; the input and output temperature probes, power driver module, and all cables in the system were inspected and all were found to be connected and functioning properly.The unit performed according to specifications upon receipt.The associated disposable set was discarded at the hospital and no lot number was available, therefore review of a specific library/retain sample and batch record information is not possible.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.The manufacturing records for this serial number were reviewed and no anomalies were identified.Without the ability to duplicate the reported alarm or investigate the disposable set, a root cause cannot be established.No patient injury was reported.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: 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: 12178518
• Report Number: 1219702-2021-00096
• Device Sequence Number: 1748599
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: 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: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown