MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER, RI-2; PUMP INFUSION

Catalog Number	903-00039A-UK
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint file #(b)(4).Has been logged for this incident for traceability.The ri-2 and disposable involved in the incident have not been returned to belmont medical technologies for evaluation.The device is being held by the user and is not in use at this time.Although the patient involved in this incident died, it was confirmed that the device did not cause or contribute to the death.Belmont has requested the return of the device in order for us to perform an investigation.Review of the device history.An air in line error generates to alert the user, and these issues are obvious to the user while interacting with the device.Infusion can be continued through other means.No other issue has previously been reported for this device.When the rapid infuser 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.In case if air is detected in the device, the rapid infuser exhibits the following alarm message: "air detection, open the door.Squeeze tubing below below detector to clear trapped air reinsert tubing and close the door".Belmont is working with the user facility to get the device involved in this incident returned for investigation.Without results of the device investigation, no conclusions can be drawn.A follow-up report will be submitted once the investigation is complete and additional information becomes available.
Event or Problem Description
Belmont received the following report via mir 2023/007/012/501/006.Set up originally for the case working fine.Machine then came up with air in giving set.Tried to rectify multiple times, changing the consumables.Machine then came up with service error every time after we had primed the line, no alarm present when this happened.Yet whilst it was saying service error and not allowing us to infuse, the volume of fluid which goes into the patient was increasing rapidly on the machine, it got to around 6000l (saying thats what we had used and was continuously going up) despite it not infusing, we know this as it wasnt connected to the patient.The machine touch screen then failed and would not work.We turned the machine off for a while and later tried again in the evening to see if this problem had rectified and it was still doing the same.
Additional Manufacturer Narrative
The device was returned by the user and reviewed by a belmont service technician.It was identified that there was a fault with the membrane switch which lead to the reported issues of the flow rate on the machine increasing by itself, and the inability to utilize the touchscreen.Root cause of the reported issue was isolated to the fault with the membrane switch of the device, however the root cause of the membrane switch fault could not be determined.It was additionally reported the device came up with air in the giving set.This reported issue could not be confirmed.No device malfunction could be verified for this reported issue.The device history was reviewed and no other issues were identified.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: PUMP INFUSION
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 17506244
• Report Number: 1219702-2023-00038
• Device Sequence Number: 17701228
• Product Code: FRN
• UDI-Device Identifier: 00896128002817
• UDI-Public: 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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 Catalogue Number: 903-00039A-UK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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