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

Model Number 903-00004P

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

In a patient undergoing major surgery, the "rapid infusor 2" was connected to both legs of a shaldon catheter using a "dual patient line" y-line set and was not used for a few hours.When the system was checked visually before the start of the transfusion, a large amount of air was noticed in the system.Since at that time it could not be ruled out with certainty that air had remained in the system due to an error in the preparation (unlikely, but there was a team change in the meantime), the air was drawn off via the injection connectors.It was noticed that there was liquid on the floor below the y-piece.A pressure test showed a clear leak.It can be assumed that the air also got into the system via this leak, because the infusion solution had escaped due to gravity while the vehicle was standing still.The patient was not harmed because air and leaks were noticed in good time and the y-system was removed.We secured the system and shut down all other systems.

Manufacturer Narrative

The internal complaint file #(b)(4) has been logged for this incident for traceability.The device involved in the incident was not returned to belmont medical technologies for evaluation.The patient involved in this event was not harmed.In a patient undergoing major surgery, the "rapid infusor 2" was connected to both legs of a shaldon catheter using a "dual patient line" y-line set and was not used for a few hours.When the system was checked visually before the start of the transfusion, a large amount of air was noticed in the system.Since at that time it could not be ruled out with certainty that air had remained in the system due to an error in the preparation (unlikely, but there was a team change in the meantime), the air was drawn off via the injection connectors.It was noticed that there was liquid on the floor below the y-piece.A pressure test showed a clear leak.It can be assumed that the air also got into the system via this leak, because the infusion solution had escaped due to gravity while the vehicle was standing still.The patient was not harmed because air and leaks were noticed in good time and the y-system was removed.We secured the system and shut down all other systems.When the rapid infuser ri-2 recognizes a situation that is compromising, effective infusing, it stops pumping, heating, moves the valve wand into recirculate position,displays alarm message, instructions for corrective measure, and sounds an audible alarm and displays an alarm message with instructions for corrective measure.In the event of an "air detection", the rapid infuser exhibits the following alarm message: "air detection, open the door.Squeeze tubing below detector to clear trapped air reinsert tubing and close the door".The operator's manual also provides possible conditions and recommended operator actions.Certain other conditions that could have lead to air bubbles includes air in the line, tubing in the air detection sensor not seated firmly in the detector or leak in the disposable.The operator's manual also consists of warning: "before continuing, you must inspect and make certain that the patient line is completely primed and free of air.Any air bubbles after the valve wand in the patient line must be removed before the procedure can safely continue".Belmont has followed up with the distributor to obtain additional information from the user and to obtain the return of the device for investigation.The dual patient line used in the incident is detailed as having been sent to belmont by the distributor however it has not yet been received.The device has not yet been evaluated by belmont, nor is there information about the lot number of the device to allow the review of device manufacturing records.There is no indication of patient harm as a result of the reported incident.

Manufacturer Narrative

The device that was involved in the incident having lot number 2021-10-04, was not provided by the end user, however the user provided video of the incident which confirmed that there was a leak in the disposable.Without the ability to review the actual device we are unable to determine if the leak was process or handling related in this specific instance.The end user returned the remaining unused quantity of the product (p/n (b)(6)) having lot number 2021-10-04 to belmont for investigation and replacement.Belmont tested the returned products as well as a lot retain sample.Of the 25 tested samples, 2 samples demonstrated a leak.No other complaints were received for lot 2021-10-04.Lot 2021-10-04 was manufactured in october 2021 having lot quantity 2700.All products have been distributed, and no product remains in stock.Total of 4 samples from the 2700 produced were confirmed to leak, indicating an incidence rate of 0.15%.A rate of 0.15% correlates to an occasional risk factor and this aligns with the rate determined in the product risk management file, confirming no increase in the trend.Although a root cause could not be confirmed, belmont has reviewed the manufacturing method of the dual patient line in effort to eliminate potential variability caused by manual application of solvent.We will continue to monitor and trend similar reports 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: 16022859
• MDR Text Key: 308458685
• Report Number: 1219702-2022-00046
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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
• Device Operator: Health Professional
• Device Model Number: 903-00004P
• Device Catalogue Number: 903-00004P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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