MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number RI-2

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has not been returned to belmont for investigation, nor was information about the disposable set provided; therefore, we are unable to confirm the report that the device would not infuse blood higher than 90 ml/min.The system will reduce the infusion rate in order to keep the pressure in the line under the pressure limit, which may cause the flow rate to slow down or prevent it from reaching the set rate.In the event that the flow rate is slowing down or will not go at the set rate, the operator's manual provides the following recommended operator actions: 1) "check and remove kinks or obstructions in the tubing"; 2) "use the appropriate infusion set recommended in the guide, match the infusion set to flow rate and fluid type"; and 3) "increase flow by increasing the pressure limit.Change the pressure limit in calibration/setup to a higher limit (maximum pressure limit is 300 mmhg)".As high pressure may occur if the infusion site is not well placed or the catheter bore size is too small, the operator's manual instructs the user: "select an appropriate cannula size for the decided flow rate" and provides a chart to help the user choose an appropriate cannula size for the desired flow rate and infusate.The manual also cautions that "a single dedicated intravenous access should be used exclusively for infusing blood components and solutions compatible with blood." the manufacturing records for this serial number were reviewed and no anomalies were found during the manufacturing process.Without further information, it is difficult to determine what occurred.Belmont will continue to follow up with the user facility to obtain additional details about the case.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont received a medwatch report (uf/importer report # (b)(4)) from the department of health & human services, about an event that reportedly occurred in (b)(6) 2020: "belmont blood delivery system would not infusing blood higher than 90ml/minute.Troubleshooting by removing the cap did not change the delivery rate.The defective device was removed and a second device was immediately obtained and all blood product ordered were delivered to the patient.The defective device was sent to the biomed for evaluation.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• 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: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 10610869
• MDR Text Key: 231800667
• Report Number: 1219702-2020-00078
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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