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

Model Number FMS 2000

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser involved in the incident has not been returned to belmont for investigation.The unit power may be affected by an issue with the ac power source or power cord connection, however without investigating the device a root cause cannot be established.The operator's manual provides ac input voltage requirements for operating the rapid infuser, as well as a troubleshooting guide including possible conditions and recommended operator actions in the event that the unit has no power.The manufacturing records and service records for this serial number were reviewed and no anomalies were identified; the unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2011.It was reported that the user was able to restart the unit and finish the case; no patient injury was reported.Should additional information become available, a supplemental report will be provided.

Event Description

The user facility reported that the rapid infuser, fms 2000 shut down momentarily during a case.The user was able to repower the unit and complete the procedure.

• 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: 11325945
• MDR Text Key: 231978249
• Report Number: 1219702-2021-00023
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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