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

Model Number	RI-2
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation.We have reached out to the distributor for additional information and to request that the unit be returned to belmont for evaluation.A review of the manufacturing records indicated nothing notable.It was reported that there was no injury to the patient.When more information becomes available, a follow-up report will be submitted accordingly.
Event or Problem Description
The user facility reported that the rapid infuser was used to infuse 12 units of blood, and then ran on battery mode while the patient was moved to ct.When it was later plugged back into the same socket, the unit tripped the circuit breaker.

• 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: 8097844
• Report Number: 1219702-2018-00045
• Device Sequence Number: 14151226
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 903-00039A-UK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1