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

Model Number	3.0 LITER RESERVOIR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 3.0 liter reservoir involved in the incident has not been returned for investigation.A review of the photographs provided by the user facility indicated that spikes were missing from the tubing as reported by the user, however, without evaluating the set it is difficult to determine what caused the spikes to detach.All 3.0 liter reservoirs are 100% visually inspected prior to release.The manufacturing records for this lot were reviewed and no anomalies were observed.We have not received any other complaints related to this lot number.It was reported that a new 3.0 liter reservoir was connected and the case continued without further problems.No patient injury was reported.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Belmont's sales representative received a complaint from the user facility and relayed the following report: "during liver transplant case the providers were infusing blood products and noticed leaking.The anesth tech noticed that the priming tubing was missing spikes and the bags were being inserted directly into the tubing, which caused the leakage.New lvr was connected and case continued with no further problems.".

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10399505
• Report Number: 1219702-2020-00057
• Device Sequence Number: 11555257
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)230531(10)20200504
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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 Expiration Date: 05/31/2023
• Device Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2020-05 04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1