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	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Belmont medical technologies requested return of the 3.0 liter reservoirs for investigation, but they have not yet been received.The library/retain sample for this lot was reviewed and no manufacturing issues were noted.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All 3.0 liter reservoirs are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of complaints for the past three years indicates that this was an isolated incident; additionally, there have been no other complaints related to this lot number.However, without evaluating the implicated sets it is difficult to determine what occurred in this case.The user did not report any harm to the patient.We will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Belmont's distributor received a complaint from the user facility that the spikes on p/n 903-00018p came loose from the tubing on three occasions (b)(6) 2020, which made it "very troublesome to change fluid/blood bags.".

• 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: 10429290
• Report Number: 1219702-2020-00062
• Device Sequence Number: 3155700
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)221231(10)20191201
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K091855
• 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): 08/19/2020

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: 12/31/2022
• Device Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2019-12 01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1