MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION ENGLISH, RAPID INFUSER RI-2, 120V, 750 ML/MIN; WARMER, THERMAL, INFUSION FLUID

Model Number	903-00039
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Belmont infuser being used for massive transfusion, when smoke smell noted and machine beeping.Tubing noted to be scorched when removed.

• Brand Name: ENGLISH, RAPID INFUSER RI-2, 120V, 750 ML/MIN
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston rd; billerica MA 01821
• MDR Report Key: 13844676
• Report Number: 13844676
• Device Sequence Number: 14456320
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022
• Report Date (Section F): 03/17/2022

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
• Device Model Number: 903-00039
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2022
• 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: Male
• Date Report Sent to FDA: 03/17/2022