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

Model Number	FMS 2000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Exsanguination (1841); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser has been returned to belmont for investigation.Due to the holidays and year-end inventory, the investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed; the unit had not been returned to belmont for evaluation since 2010.We have contacted the user facility to obtain additional information about the incident, as the "problem" experienced with the rapid infuser was not specified.However, it is evident by the report that the rapid infuser did not directly contribute to patient harm.Without additional information, it is difficult to determine what occurred in this case at this time.Upon completion of the investigation, a follow-up report will be submitted accordingly.
Event or Problem Description
The hospital biomed reported that the overnight staff experienced a "problem" while using the rapid infuser on a patient.By the time they were able to retrieve another belmont, the patient had "bled out".The staff did not provide the biomed with any further details, other than there may have been an "occlusion".No other details were available.The biomed suggested that a tubing clamp may have been missed, but requested that the unit be evaluated.
Additional Manufacturer Narrative
The rapid infuser, fms 2000 involved in the incident was returned to belmont for investigation and was tested according to our standard operating procedures.We were unable to detect any issues with the device; the unit performed according to our specifications upon receipt.The disposable set involved in the incident was not returned, nor was a lot number available.The user facility did not elaborate on the "problem" experienced with the device.Without additional information, it is difficult to determine what occurred in this case.The rapid infuser did not directly contribute to patient harm.The manufacturing records for this serial number were reviewed and no anomalies were identified; the unit had not been returned to belmont for service or preventive maintenance since 2010.Should additional information become available, a supplemental report will be provided.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 9603875
• Report Number: 1219702-2020-00005
• Device Sequence Number: 458264
• Product Code: LGZ
• UDI-Device Identifier: 10896128002012
• UDI-Public: (01)10896128002012
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K032674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: 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: 01/08/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1