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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The 3.0 liter reservoir involved in the incident was not available for investigation.A review of photographs provided by the user facility indicates evidence of potential residual adhesive in the tubing of the 3.0 liter reservoir, however the photographs are not detailed enough to determine the actual condition of the tubing.Without investigating the set, a root cause cannot be determined.The manufacturing batch records for this lot were reviewed and no related anomalies were identified.A review of past complaints indicates only one other report related to this lot number.All 3.0 liter reservoirs are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.It was reported that the reservoir was replaced; no patient injury was reported.Belmont 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 report from the user facility that the spikes of a 3.0 liter reservoir came loose during a case.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 10826646
• MDR Text Key: 216137440
• Report Number: 1219702-2020-00099
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)230531(10)20200504
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2020

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 Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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