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

Model Number	RI-2
Medical Device Problem Codes	Infusion or Flow Problem (2964); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation.The manufacturing records for this serial number were reviewed and nothing notable was found.The user facility was unable to provide the disposable set used in the case, nor a lot number.When the rapid infuser exhibits a "high pressure" alarm, the messages on the screen instruct the user: "high pressure detected check patient line for blockage" and "high pressure detected check recirc line for blockage." in addition, page 17 of the operator's manual offers additional recommended operator actions and references the guide "match the infusion set to flow rate and fluid type" on page 10 of the manual.This guide contains a chart to help the user choose an appropriate cannula size for their desired flow rate and infusate.The cannula size used in this case was not reported.We have reached out to our distributor to try to obtain this information.It was reported that the procedure was completed successfully and there was no harm to the patient.Without additional information, it is difficult to determine what occurred in this case.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
Our distributor received a complaint from the user and relayed the following report: "it started to clog in the small reservoir and also in the patient line.The system was flushed with bolus infusion during the procedure, the disposable was changed due to the clog and the procedure could proceed without problems.The clinic has not provided the reservoir lot number and hasn't saved the disposable set (thrown away).Pictures." our distributor then followed up with the following information: "the system was used under an operation for spinal stenosis with an estimated time of almost 10 hours.The problem occurred after a total of 8 hours of infusion.And the system had been used for transfusion of both prbc and ffp no ringer lactate/acetate was infused through the system.After the clot was detected (the system alarmed for high pressure) they changed the disposable and continued the procedure without problem.The patient was not injured.Unfortunately, they haven't saved the lot on the disposable and has thrown it in the garbage.(they saw it as a problem with slow infusion or no infusion during a long procedure).".

• 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
• MDR Report Key: 8441928
• Report Number: 1219702-2019-00014
• Device Sequence Number: 13861379
• Product Code: LGZ
• UDI-Device Identifier: 00896128002794
• UDI-Public: (01)00896128002794
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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: 903-00037A-SW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1