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

Catalog Number 403-00412

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The internal complaint file # (b)(4) has been logged for this incident for traceability.The ri-2 involved in the incident was returned to belmont medical technologies (uk site) for evaluation but the disposable used is not available since it was discarded.Although the patient involved in the incident died, it was confirmed by the clinical staff that the device did not contribute to death.It was reported that the device stopped working and there was an error message to say the driver had overheated with a system error #210.Dealing with the error caused a significant delay during a traumatic event.On reviewing the manual, it says that 'power driver module overheating' should display' system error #206' rather than the reported error #210.Upon further follow-up with the user facility, the following additional information was obtained- the device had been primed and had then infused 8 * 300ml of blood into the patient before the error occurred.The user had previously identified error #210 as having been displayed but we have been advised this was chosen from the user instructions as a 'best fit' error code because the original number could not be recalled.The user has assured that the message did display that something had overheated and that a new infusion set should be used, which did clear the error.There is no information on what was infused, certain infusates are contraindicated and can lead to overheating 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 displays 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.The evaluation of the device exhibited no other faults/failures.The unit performed according to our specifications upon receipt.Belmont service department upgraded the system to the latest software revision.To ensure that this unit performs according to our specifications, it was operated at elevated temperature for 48 hours.Upon completion, a final functional test, an electrical safety test, and a final inspection were performed.The unit passed all test specifications and inspection requirements.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

Event Description

It was reported that the device stopped working and there was an error message to say the driver had overheated with a system error #210.Dealing with the error caused a significant delay during a traumatic event.On reviewing the manual, it says that 'power driver module overheating' should display' system error #206' rather than the reported error #210.

Manufacturer Narrative

The ri-2 having s/n:(b)(6) involved in the incident was returned to belmont medical technologies (uk site) for evaluation but the disposable used was not available since it was discarded.Although the patient involved in the incident died, it was confirmed by the clinical staff that the device did not contribute to the death.There is no information on what was infused, but certain infusates are contraindicated and may lead to clot formation inside the heat exchanger, which can block blood flow and result in an "over temperature" alarm.The evaluation of the device exhibited no faults/failures.The unit performed according to our specifications upon receipt.Belmont service department upgraded the system to the latest software revision.To ensure that this unit performs according to our specifications, it was operated at elevated temperature for 48 hours.Upon completion, a final functional test, an electrical safety test, and a final inspection were performed.The unit passed all test specifications and inspection requirements.No device malfunction could be verified, and the root cause could not be determined.We will continue to monitor this type of incident closely and take further corrective and preventive actions if required.

• Brand Name: THE BELMONT RAPID INFUSER, RI-2
• Type of Device: 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: 15974353
• MDR Text Key: 308454048
• Report Number: 1219702-2022-00045
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 403-00412
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1