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

Model Number	DUAL PATIENT LINE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dual patient line was discarded at the hospital and was therefore not available for investigation.It was reported that there was no damage to the disposable set as a result of the reported "over temperature" incident.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 dual patient lines are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.The rapid infuser, ri-2 involved in the incident was evaluated by the distributor and performed according to specification.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 or Problem 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 reported the following: "during 'total abdominal hysterectomy', #102 over temperature error occurred using ri-2.The user has replaced the new disposable kit." this report is for the dual patient line; separate reports will be entered for the 3-spike disposable set and 3.0 liter reservoir.

• 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: 10681430
• Report Number: 1219702-2020-00087
• Device Sequence Number: 14255211
• Product Code: LGZ
• UDI-Device Identifier: 00896128002053
• UDI-Public: (01)00896128002053(17)221130(10)20191104
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 11/30/2022
• Device Model Number: DUAL PATIENT LINE
• Device Catalogue Number: 903-00004P
• Device Lot Number: 2019-11 04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1