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

Model Number	RI-2
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The rapid infuser, ri-2 involved in the incident was returned to belmont medical technologies (b)(6) for evaluation.The user reported that the ri-2 displayed the following alarm message: "check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists." this is the alarm message displayed when the unit experiences a system error #101, heating fault alarm.Upon receipt at belmont's service department in (b)(6), the service engineers were unable to reproduce the reported alarm after prolonged testing.The device went through full preventive maintenance testing and no alarms were observed.All tests and inspections passed.The system performed according to specifications.The following conditions may result in a "heating fault" alarm: heater fault; wet, dirty, or blocked disposable set windows; wet, dirty, or blocked ir probe; ir probe failure.In addition to displaying the reported alarm message, the operator's manual instructs the user: "check disposable set and flow path for occlusions.Make certain the windows on the disposable set and the ir probes are clean and dry.Clean surfaces with moistened soft cloth if necessary.Dry off surfaces before continuing.Press retry to continue.Power off and service machine if error persists." the temperature probes should be cleaned before or after each use according to the service and preventive maintenance schedule/instructions provided in the operator's manual, as dirty, wet, or blocked temperature probes can cause the rapid infuser to exhibit a "heating fault" alarm.Without the ability to reproduce the reported alarm, a root cause cannot be established.The "heating fault" alarm could have occurred due to an occlusion in the flow path of the disposable set, however there was no report from the field of such an event.It was reported that there was no harm to the patient.Belmont will continue to monitor and trend similar reports of this nature.
Event or Problem Description
Belmont medical technologies received the following report (incident number (b)(4)) from the medicines and healthcare products regulatory agency (mhra) in the (b)(6): "belmont ri-2 device stopped working and displayed error message 'check temperature probes for blockage.Clean windows.Press retry to continue.Service machine if error persists.'".

• 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
• 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: 13518342
• Report Number: 1219702-2022-00007
• Device Sequence Number: 4158093
• Product Code: LGZ
• UDI-Device Identifier: 00896128002817
• UDI-Public: (01)00896128002817
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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-UK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown