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

Model Number 3.0 LITER RESERVOIR

Device Problem Overheating of Device (1437)

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

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

The 3.0 liter reservoir involved in the incident has not been returned for investigation.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 past complaints indicates that there have been no other complaints related to this lot number.When the rapid infuser detects a situation that is compromising effective infusion, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.It was reported that there was no 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 involving three disposable products (3-spike disposable set, 3.0 liter reservoir, and dual patient line) and relayed the following report: "during open heart surgery, #102 over temperature error occurred after about 5 hours of using ri-2.The user has replaced the new disposable kit." this report is for the 3.0 liter reservoir; separate reports will be entered for the 3-spike disposable set and dual patient line.

• 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: 10584575
• MDR Text Key: 209021734
• Report Number: 1219702-2020-00073
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)230131(10)20200103
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141654
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2020-01 03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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