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

Model Number	RI-2
Medical Device Problem Codes	Smoking (1585); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser was returned to belmont for investigation.We were unable to duplicate the report of the device producing large amounts of smoke or fire; upon receipt there was a great deal of blood contamination on the housing, otherwise the unit performed according to specification.We were unable to confirm the report of burn residue in the heating element, as the 3-spike disposable set involved in the case was not available for investigation.It was reported that the system was primed with lactated ringer's (lr).The use of lr 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, 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's sales representative received a complaint from the user facility and reported the following: "received email today at 1151 am from dr (b)(6) that early this morning one of the anesthesiologist, dr.(b)(6), used the loaner belmont for a mtp case in ob.During use at 750ml/hr the belmont started producing large amounts of smoke/caught fire.It was quickly disconnected from the patient and removed.There is burn residue in the location of the heating element." the user subsequently reported that lactated ringer's solution was used in combination with blood products.

• 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: 10775563
• Report Number: 1219702-2020-00092
• Device Sequence Number: 3088605
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 903-00039
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1