MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET; THERMAL INFUSION FLUID

Model Number	903-00006P
Medical Device Problem Codes	Melted (1385); Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2024
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 the incident has not been returned to belmont medical technologies for evaluation.The disposable set involved in this incident was not returned to belmont for evaluation since it was discarded.The incident was initially reported to belmont by the user facility on (b)(6) 2024 that there was an incident during a case with no associated patient harmed.Based upon the information provided, belmont documented the incident to be non-reportable at that point.Subsequently, belmont was informed on (b)(6) that the patient expired, however the device was not the cause of death, which per our procedure requires us to submit a report.Although 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.In case of overheat alarm, 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.Other methods can be used to infuse the patient.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 operator's manual also provides possible conditions and additional recommended operator actions.The operator's manual provides instructions on installing the disposable set and additional recommended operator actions.The step-by-step procedures 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.Evaluation: the reported issue could be confirmed from the images provided.This issue is consistent with a clot forming in the heat exchanger leading to the set overheating due to the inability of the fluid to pass through and carry away the heat delivered to the heat exchanger.A precise root cause of this clot could not be determined.The set was discarded and could not be sent for further evaluation.We tested a retain sample from the same lot as the cited sample and no issue were identified.The device history of the 2 ri-2 units potentially used in the event were reviewed, and no similar incidents were identified.Belmont will continue to monitor this type of incident closely and take further corrective and preventive actions if required.
Event or Problem Description
The user facility reported that there was an overheat error during a case by using whole blood.The disposable set was removed and installed on another ri-2.The staffs were able to infuse at 500 ml/min for 30 minutes nonstop and that was when the team noticed a smell and saw smoke.The disposable set was discarded.There were 2 units used, one from er which i do not know the serial number, the other was one of ours but i do not recall which of the 2 units we have, one serial number is (b)(6), the other is (b)(6), the tubing lot number is 20240415.

• Brand Name: 3-SPIKE DISPOSABLE SET
• 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: 20487103
• Report Number: 1219702-2024-00051
• Device Sequence Number: 3506680
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 903-00006P
• 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: 08/09/2024
• 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): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown