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

Model Number RI-2

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has not been returned.We have contacted the user facility to obtain information about the status of the patient and to request that the unit be returned to belmont for investigation.The manufacturing records for this serial number were reviewed and nothing notable was observed.Without additional information, it is difficult to determine what occurred in this case.We will continue to follow up with our investigation and should additional information become available, a supplemental report will be submitted.We will continue to monitor and trend similar reports of this nature.

Event Description

The user facility reported the following: "frozen touch screen.Dr.(b)(6) mentioned that during a trauma the night of (b)(6) 2019, our belmont froze up.After 20 minutes of use, the touch screen wouldn't allow him to adjust the rate.He flipped the switch in the back in order to restart the machine but it wouldn't turn off.He had to unplug the machine to get it to turn off.He plugged it back in, flipped the switch, and restarted the process without any issue.Another 20 minutes passed and the machine froze up again.

• 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: 9508580
• MDR Text Key: 195578596
• Report Number: 1219702-2019-00104
• 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: 12/21/2019

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: 903-00037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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