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

Model Number	RI-2
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, ri-2 has not been returned to belmont for investigation.The user facility was unable to provide the specific error code experienced, however based on the description of the alarm message it was determined that the unit exhibited a system error #102, over temperature alarm.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." without knowledge of the infusates used during the case or the ability to evaluate the device, we are unable to definitively discern the root cause of the problem.Known contraindicated products such as pharmaceuticals, calcium, and platelets should not be used, as they can compromise the anticoagulants in citrated blood and promote clotting, which can lead to clot formation inside the heat exchanger and block blood flow.If this occurs, the stainless steel rings inside the heat exchanger will become overheated and cause an over temperature / overheating issue.Belmont has contacted the initial reporter to obtain further information about the case, including the infusates used, the serial number of the unit, and the lot number of the disposable set.As of the date of this report, no additional information has been provided.Without the ri-2 serial number or lot number of the disposable set, a review of the manufacturing records is not possible.It was reported that the patient deceased.There has been no allegation that the ri-2 directly contributed to the patient death.Should the device be returned for investigation or additional information become available, a supplemental report will be provided.
Event or Problem Description
The user facility reported the following incident involving a belmont rapid infuser, ri-2: "the belmont machine was on a patient that we coded for 2.5 hours.There was an error code of either 102 or 104.It said the primate was too hot and remove from service.We turned it off and back on with the same error code.It said something like to prime a new set.The patient expired before i could prime another line.".

• 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: 13486185
• Report Number: 1219702-2022-00006
• Device Sequence Number: 5387322
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: 10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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