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

Model Number RI-2

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

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

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser has been returned to belmont for evaluation.Evaluation of the unit is in process; a follow-up report will be submitted.Without results of the evaluation, it is difficult to determine what occurred in this case.A review of complaints for the past three years indicates that this was an isolated incident.It was reported that there was no injury to the patient.A follow-up report will be submitted upon completion of the investigation.

Event Description

The user facility reported that the display intermittently displayed double images.

Manufacturer Narrative

The rapid infuser, ri-2 was returned to belmont for investigation.We were unable to confirm the complaint that the unit intermittently displayed double images.Upon receipt the unit was unable to power up due to a damaged computer board caused by saline contamination, and it was also noted that the membrane switch was cracked, suggesting that the unit suffered an impact.Fluid contamination can cause problems with the membrane switch and cpu board interface, which may have resulted in double images on the display.The operator's manual cautions the user: "immediately wipe any spills from the device." the service and preventive maintenance schedule outlined in the manual also instructs the user to check the unit seals every six months.The manufacturing records for this serial number were reviewed and no anomalies were identified.A review of the service records indicates that the unit has previously been returned to belmont for a cracked display as the result of an accidental impact.It was reported that there was no injury to the patient.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10440054
• MDR Text Key: 204023604
• Report Number: 1219702-2020-00064
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10896128002760
• UDI-Public: (01)10896128002760
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1