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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a visit to the hospital, belmont's sales representative was informed of a previous incident in which a spike came loose from a 3.0 liter reservoir during a procedure.The date of the incident was unknown.We have requested the reservoir back for investigation, but it has not been returned.An inspection of the retention sample from the associated lot, as well as the preceding and subsequent lots, revealed no anomalies or defects.The manufacturing batch records of the associated lot were also reviewed and nothing notable was observed.Should additional information become available, a supplemental report will be submitted.We will continue to monitor and trend similar reports of this nature.
Event or Problem Description
During a visit with the user facility, the belmont sales representative received a complaint involving a 3.0 liter reservoir disposable set, in which one of the spikes came loose from the tubing and caused a blood spillage.

• 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: 8363857
• Report Number: 1219702-2019-00010
• Device Sequence Number: 1915345
• Product Code: LGZ
• UDI-Device Identifier: 10896128002005
• UDI-Public: (01)10896128002005(17)210930(10)20180903
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 09/30/2021
• Device Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2018-09 03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1