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

Model Number FMS 2000

Device Problem Temperature Problem (3022)

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

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser was received for evaluation on (b)(6) 2019.The investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that the unit was not used in a procedure and no patient injury was reported.We have contacted the user facility for additional information.A follow-up report will be submitted upon completion of the investigation.

Event Description

Belmont's sales representative received a complaint from the user facility and relayed the following report: "electrical cord burnt and melted at base of machine while plugged into outlet in or hallway.Smoke caused fire alarm at 1857 on (b)(6) 2019.Ri-2 was found smoking by or staff who unplugged the device prior to fire department response.".

• 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: 9492262
• MDR Text Key: 197961700
• Report Number: 1219702-2019-00102
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2019

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: FMS 2000
• Device Catalogue Number: 903-00001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2016
• 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