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

Model Number RI-2

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Date 08/31/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has been received for evaluation, but the investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed.We have reached out to the distributor to obtain additional information from the user facility.Upon completion of the investigation, a follow-up report will be submitted accordingly.

Event Description

It was reported that the rapid infuser exhibited a "valve fault" alarm (system error #208), and that there were double images on the display.Our distributor relayed the following report: "the customer informed us that the system has produced the error code 208 during normal use.The error showed up after 2 hours and can not be reset.It seems to be a permanent problem now.".

• 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: 9142823
• MDR Text Key: 196251261
• Report Number: 1219702-2019-00069
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 40896128002754
• UDI-Public: (01)40896128002754
• Combination Product (y/n): N
• Reporter Country Code: WZ
• 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: 10/01/2019

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: 903-00037A-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 09/01/2019
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• 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