MAUDE Adverse Event Report: BELMONT INSTRUMENT LLC THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number	RI-2
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor evaluated the device and found that it performed according to specifications.The distributor has been contacted for additional details about the event and status of the patient.The hardware device has been received by belmont for evaluation.The investigation is not yet complete.A follow-up report with all additional relevant information will be submitted upon completion of the investigation.
Event or Problem Description
The user facility reported that the disposable set was deformed following an overheat incident that occurred during a case.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT LLC; 780 boston road; billerica MA 01821
• MDR Report Key: 7924464
• Report Number: 1219702-2018-00035
• Device Sequence Number: 1526529
• Product Code: LGZ
• UDI-Device Identifier: 70896128002038
• UDI-Public: (01)70896128002038
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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-I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1