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

Model Number RI-2

Device Problem Overheating of Device (1437)

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

Event Date 07/26/2020

Event Type  malfunction  

Manufacturer Narrative

Belmont medical technologies has requested that the rapid infuser be returned for investigation, but the unit has not yet been received.The hospital biomed tested the device and was unable to confirm the complaint of an "overheat incident".When the rapid infuser detects a situation that is compromising effective infusion, the system stops pumping and heating, closes off the line the to the patient, sounds an audible alarm, and displays measures for corrective action.The user facility did not report any harm to the patient.We will continue to follow up with the user facility to obtain additional details about the case, and to request that the unit be returned to belmont for investigation.Without further information, it is difficult to determine what occurred in this incident.Should additional information become available, a supplemental report will be submitted accordingly.

Event Description

The hospital biomed relayed a report from the er that there was an "overheat incident" during a case on (b)(6) 2020.The biomed was unable to confirm the error.

• 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: 10450152
• MDR Text Key: 204457555
• Report Number: 1219702-2020-00065
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002630
• UDI-Public: (01)10896128002630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/25/2020

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: RI-2
• Device Catalogue Number: 903-00037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1