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

Model Number RI-2

Device Problem Temperature Problem (3022)

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 not been returned to belmont for investigation.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.While the reported "over temperature" alarm could not be reproduced, upon receipt it was identified that the input and output tempreature probe sensors were dirty, which caused the unit to exhibit a "heating fault" alarm.Wet, dirty, or blocked temperature probes can cause both "heating fault" and "over temperature" alarms.The temperature probes should be cleaned before or after each use according to the service and preventive maintenance schedule provided in the operator's manual.Instructions for cleaning the temperture probes are provided under routine maintenance in the manual.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.

• 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: 9649977
• MDR Text Key: 195067289
• Report Number: 1219702-2020-00010
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002763
• UDI-Public: (01)00896128002763
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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