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 Type  malfunction  

Manufacturer Narrative

The user facility reported that the rapid infuser will be returned to belmont for investigation; the unit has not yet been received.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 an alarm message with instructions for corrective measure.The operator's manual also provides possible conditions and additional recommended operator actions.The manufacturing records for this serial number were reviewed and nothing notable was observed.The hospital biomed stated that no patient harm was reported.Without further information, it is difficult to determine what occurred in this incident.Should additional information become available, a supplemental report will be submitted.

Event Description

The hospital biomed relayed a report from the user that the belmont rapid infuser, ri-2 exhibited an "overheat" alarm.

Manufacturer Narrative

The rapid infuser involved in the incident was not returned to belmont for investigation, therefore the reported "overheat" alarm could not be confirmed.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 an alarm message with instructions for corrective measure.The operator's manual also provides possible conditions and additional recommended operator actions.The manufacturing records for this serial number were reviewed and nothing notable was observed.The hospital biomed stated that no patient harm was reported.Without further information, it is difficult to determine what occurred in this case.Belmont will continue to monitor and trend similar reports of this nature.

• 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: 10610641
• MDR Text Key: 209368938
• Report Number: 1219702-2020-00077
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• 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