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	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser and associated disposable set were returned for investigation.The disposable set showed evidence of high temperature damage as reported, however, no problems were detected with the hardware; the rapid infuser performed according to specification upon receipt.It was reported that hartmann's solution was in use at the time of the incident.The use of lactated ringer's and other calcium-containing solutions is contraindicated, as adding calcium to citrated blood will compromise the anticoagulants in the blood and promote clotting, which can lead to clot formation inside the heat exchanger.If clotting occurs and blocks blood flow, the stainless steel rings inside the heat exchanger will become overheated and cause an over temperature/overheating issue.A warning statement, "do not mix lactated ringer's or other solutions containing calcium with citrated blood products," is provided in the operator's manual, in the quick reference guide, and on a label affixed to the rapid infuser itself.The manufacturing and repair records for this serial number were reviewed and no anomalies were identified.It was reported that there was no injury to the patient.Belmont will continue to monitor, and trend similar reports of this nature, and take further action if required.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont medical technologies' distributor received a complaint from the user facility and reported the following, "belmont ri-2, was prepped for use by perfusion team.Alarm was raised when smoke came from device.Disposable set melted in unit.Verbal confirmation was provided by the reporting customer that hartmann's solution was being used in the device at the time of the incident.".

• 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: 10915164
• Report Number: 1219702-2020-00110
• Device Sequence Number: 11567223
• Product Code: LGZ
• UDI-Device Identifier: 00896128002817
• UDI-Public: (01)00896128002817
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2020

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: 903-00039A-UK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1