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

Model Number 3.0 LITER RESERVOIR

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2020

Event Type  malfunction  

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 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, (b)(6) 2020, and (b)(6) 2020), which made it "very troublesome to change fluid/blood bags.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 10429340
• MDR Text Key: 204573822
• Report Number: 1219702-2020-00061
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)221231(10)20191201
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1