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

Model Number RI-2

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has been returned to belmont for evaluation, but the investigation is not yet complete.The manufacturing records for this serial number were reviewed and nothing notable was observed; the unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2016.We have contacted the user facility to obtain additional information about the case, including the type of infusate used during the procedure and information about the disposable set.When the rapid infuser recognizes a situation that could compromise safe and effective infusion, 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.It was reported that the rapid infuser was subsequently tested both in the operating room and by the hospital biomed, with no problems observed.There was no injury to the patient.Without additional information, it is difficult to determine what occurred in this case at this time.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont's sales representative received a complaint from the user facility and relayed the following report: "system error 102, over temperature.Incident occurred in labor and delivery 5 minutes into infusing.They swtiched to red outlet and had the same problem so switched devices and had the same problem.They took the infuser to the operating room and tested each device and had no problem.They had biomed check all 3 machines and they had no problem.".

Manufacturer Narrative

The rapid infuser, ri-2 involved in the incident was returned to belmont for investigation.We were unable to duplicate the complaint of an "over temperature" alarm after inspection and testing; the unit performed according to specification.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.There is no information available about the fluids infused during the procedure.Certain infusates are contraindicated and may lead to clot formation inside the heat exhcanger, which can block blood flow and result in an "over temperature" alarm.It was reported that the rapid infuser was subsequently tested both in the operating room and by the hospital biomed following the incident, with no problems observed.There was no injury to the patient.The manufacturing records for this serial number were reviewed and no anomalies were identified.Belmont will continue to monitor and trend similar reports of this nature.

• 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
• MDR Report Key: 9649897
• MDR Text Key: 198521907
• Report Number: 1219702-2020-00009
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002763
• UDI-Public: (01)00896128002763
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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: RI-2
• Device Catalogue Number: 903-00039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1