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

Model Number	903-00037
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The internal complaint file#: (b)(4) has been logged for this incident for traceability.The ri-2 involved in this incident was not returned to belmont for evaluation.The user confirmed that the disposable set involved in this incident was discarded therefore could not be sent for review.Per medsun user facility report#: (b)(4), the event of event is march 2024 but the user facility did not inform belmont about this incident when it actually occured.We became aware of this incident on september 25th, after receiving the medsun report therefore, reporting this now.Although the patient involved in this incident expired, the user facility confirmed that device was not a contributing factor.Belmont contacted the user facility to collect additional information on the event and to check what was infused but we did not receive clear responses.They said only blood was infused, no further details were available.A 102 error message (over temperature) is generated to alert the user of the condition of the device.Infusion can be continued through other means.There is no indication of the use of contraindicated fluids.Certain infusates such as calcium, and platelets should not be used, as they can compromise the anticoagulants in citrated blood and promote clotting, which can lead to clot formation inside the heat exchanger and block blood flow.If this occurs, the stainless steel rings inside the heat exchanger may become overheated and cause an over temperature /overheating issue.The user will lose the ability to infuse the patient with the ri-2 during the error.A 102 alarm is generated to alert the user of the condition of the 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 the event of an "over temperature" alarm, the rapid infuser exhibits the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the user will lose the ability to infuse the patient during the event.A 102 alarm is generated to alert the user of the condition of the device.The operator manual states the following: "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.Make sure bag clamps a re open and flow is unimpeded.Make sure that the filter is not clogged.Add more fluid if fluid out.Clamp off the bag spikes and patient line and remove disposable.Power off and restart system with a new disposable.Service machine if the problem persists." a message appears on the screen to discard the disposable and blood and to restart the system with a new disposable.Infusion of the patient can be continued by other means if the error persists.The step-by-step procedure in manual has warning on installing the disposable, "do not kink or twist the tubing" and "do not apply excessive pressure to the pressure transducer.The pressure transducer can be damaged with excessive force.Do not use the system if the pressure transducer is damaged".All 3- spike sets are 100% visually inspected and 100% leak tested prior to final packaging and release for shipment from belmont medical technologies.The ri-2 involved in this incident was tested by the biomed on-site at the user facility.The validation testing was performed in order to duplicate the overheating error but they were unable to reproduce the issue after extensive testing.The 3-spike disposable set was not saved, therefore a thorough investigation of te disposable could not be performed.All disposable sets are 100% leak tested and visually inspected.No device malfunction could be verified, and the root cause could not be determined.Belmont will continue to monitor this type of incident closely and take further corrective and preventive actions if required.
Event or Problem Description
The medsun report states the following, the belmont overheated during use and was nonfunctional; would only transfuse at 50ml/min, for one minute, and shut down giving and overheating error.Patient underwent planned right rats lower lobectomy with mediastinal lymph node dissection and intercostal blocks in the morning of [redacted].He extubated and went to the recovery room for about two hours.At that time the patient rapidly dumped 900cc of blood into his chest tubes the patient was taken back to the or, intubated with a double lumen tube, prepped and draped.He underwent an anterolateral muscle sparing thoracotomy.Post-op hemorrhage resulting in hemorrhagic shock and expiration.

• 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: 20487347
• Report Number: 1219702-2024-00052
• Device Sequence Number: 11639468
• Product Code: FRN
• UDI-Device Identifier: 10896128002630
• UDI-Public: 10896128002630
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 09/25/2024
• 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