MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES RAPID INFUSER RI-2, 120V, 1000ML/MIN; PUMP INFUSION

Model Number	903-00037
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The biomed reported that i tried to set up the fbu belmont in preparation for a suspected uterine rupture.It was not booting properly.I had to borrow from main or.There was no patient impact associated with this incident.
Additional Manufacturer Narrative
The alleged incident was originally reported to belmont on 09/11/2024 and the initial decision was that it did not meet the criteria to be reportable.Subsequently, belmont received the user facility report from health canada on 09/18/2024 and the decision was per our procedure updated to reportable.The internal complaint file #(b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident has not been returned to belmont medical technologies for evaluation.This issue occurs prior to use, therefore the device would not be put into use.There was no patient involvement.The unit exhibited a calibration failure where at least one of the calibration coefficients did not match.The device was powered up in the calibration screen to prevent use of the unit during this mismatch.A precise root cause of this calibration issue could not be determined.The device history was reviewed and no other issues were identified.The unit was re-calibrated, which resolved the isue and no other issues were identified.Unit passed all pm and functional tests after calibration by the biomed.No issues found and returned to service.Although there was no patient impact and other issues noted, belmont has opened capa-000056 to further investigate this issue.As the device was not returned, no device malfunction could be confirmed.Therefore, no device malfunction could be verified, and the root cause could not be determined.Belmont will continue to monitor this issue moving forward.

• Brand Name: RAPID INFUSER RI-2, 120V, 1000ML/MIN
• Common Device Name: PUMP INFUSION
• 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: 20481008
• Report Number: 1219702-2024-00049
• Device Sequence Number: 18184106
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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 Model Number: 903-00037
• 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: 09/11/2024
• Initial Report FDA Received Date: 10/18/2024
• 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