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

Model Number	3.0 LITER RESERVOIR
Medical Device Problem Codes	Increase in Pressure (1491); Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 3.0 liter reservoir involved in the incident was returned to belmont for investigation and was tested with the normosol solution that was returned with the reservoir.The initial investigation revealed no problems with the reservoir; when tested with a rapid infuser, the device primed without issue and did not exhibit a "high pressure" alarm.The library/retain sample for this lot was inspected and no defects were observed.The manufacturing batch records for this lot were also reviewed and no related anomalies were identified.All 3.0 liter reservoirs are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates there have been no other reports related to this lot number.It was reported that while the patient responded favorably to the users' resuscitative efforts of transfusing by hand, there was a delay in care due to the reported issue.Though the issue currently cannot be reproduced by belmont in a test environment, the engineering department has been made aware of this incident.Should additional information be received to change the outcome of the performed investigation, a supplemental report will be provided.
Event or Problem Description
Belmont received a report from the physician at the hospital about an incident that occurred on (b)(6) 2020, involving a 3.0 liter reservoir: "this particular disposable device failed this morning.It was for an emergency case, pt with multiple gunshot wounds, bleeding severely, with unstable vital signs, massive transfusion protocol in progress.Upon trying to prime the belmont fms 2000 with normosol, a high pressure alarm kept going off indicating high pressure in the return line to the 3 liter reservoir.".

• 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: 10995849
• Report Number: 1219702-2020-00115
• Device Sequence Number: 3477826
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: (01)00896128002008(17)230831(10)20200802
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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 Expiration Date: 08/31/2023
• Device Model Number: 3.0 LITER RESERVOIR
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2020-08 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1