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

Model Number FMS 2000

Device Problems Device Fell (4014); Excessive Heating (4030)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser, fms 2000 has been returned to belmont for investigation.Evaluation of the unit is in process.In the event of an "over temperature" alarm, the fms displays the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.When the fms detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.It was reported that the disposable set was discarded at the hospital, and the user facility was unable to provide the lot number of the disposable set involved.Without results of the investigation, a root cause of the reported alarm cannot be established.The hospital biomed reported that the unit also suffered an accidental drop which resulted in damage to the housing, and that the touch screen is not functioning.There was no patient injury reported.The manufacturing records for this fms 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 2016.A follow-up report will be submitted upon completion of the investigation.

Event Description

The user facility reported that the rapid infuser, fms 2000 exhibited an "over temperature" alarm while treating a trauma patient.The hospital biomed also reported that the system was dropped.There is damage to the housing and the touch screen is not functioning.

• 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: 11757983
• MDR Text Key: 252392535
• Report Number: 1219702-2021-00064
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• 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