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

Catalog Number	903-00039A-D
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
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 user indicated that there was no patient impact as the incident was avoided.Belmont has confirmed with the user that there was no patient impact and that the ri-2 device has been given to the distributor in denmark.The disposable used in the in the incident has also been given to the distributor in denmark.Belmont is following up with the distributor to obtain additional information about the ri-2 unit and the disposable.Belmont contacted the user facility to confirm the serial number but the user is unable to confirm the serial number of the device involved in this incident.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 in country distributor to investigate the device in question.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
The user reported the following to the danish medicines agency.Belmont machine is always assembled in advance by a trauma nurse.The machine is therefore assembled upon the pt's arrival.The belmont bowl fills with blood, the belmont switched on and primed.Hose to the patient.Trying to start transfusion of patient, but the machine continuously displays an error source: air in the hose.The hose primed x 3 by ut, without luck.Tried to change belmont machine with same set of hoses, but this also shows air in the hose.No air is observed in the hose.Transfusion set tubing is changed.There is no patient injury associated with this incident.
Additional Manufacturer Narrative
The disposable was not returned to belmont for investigation however the ri-2 device was evaluated by the distributor and no issue was found.The distributor has confirmed that the device has not been put out of operation by the user.There was no patient harm as a result of the alleged incident and no issue could be confirmed on the device.The root cause of the alleged incident could not be determined.The device history was reviewed and no new risks were identified.All disposable sets are 100% leak tested and visually inspected prior to release.Belmont will continue to monitor this issue moving forward.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Common Device Name: THERMAL INFUSION FLUID
• 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: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 20150984
• Report Number: 1219702-2024-00041
• Device Sequence Number: 8259686
• Product Code: LGZ
• UDI-Device Identifier: 20896128002774
• UDI-Public: 20896128002774
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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-D
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown