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

Model Number	RI-2
Medical Device Problem Codes	Increase in Pressure (1491); Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser has been returned to belmont for evaluation.Evaluation of the unit is in process; a follow-up report will be submitted.In the event that the rapid infuser recognizes a situation that is compromising effective infusion, 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 rapid infuser was not attached to a patient at the time of the incident.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Belmont's distributor received a complaint from the user facility and relayed the following report: "repeated instances of 'high pressure detected' and 'temperature alarm' even when not being used.Our engineer has assessed it and found the following: customer has had repeated temperature and pressure sensors, even when the unit has not been in use (set inserted, but not running).Unreported until now.Unit recently sent to getz ((b)(6) 2020) for error 101 and passed warranty pm with no issues.".
Additional Manufacturer Narrative
The rapid infuser was returned for investigation and was tested using our standard operating procedures.We were unable to confirm the report of high pressure or temperature alarms; the unit performed according to our specifications upon receipt.In the event that the rapid infuser recognizes a situation that is compromising effective infusion, 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.The manufacturing records for this serial number were reviewed and nothing notable was observed.It was reported that the rapid infuser was not attached to a patient at the time of the incident.Should additional information become available, a supplemental report will be submitted.

• Brand Name: THE BELMONT RAPID INFUSER
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10311394
• Report Number: 1219702-2020-00052
• Device Sequence Number: 11612593
• Product Code: LGZ
• UDI-Device Identifier: 10896128002777
• UDI-Public: (01)10896128002777
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: RI-2
• Device Catalogue Number: 903-00039A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1