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

Model Number RI-2

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/13/2019

Event Type  malfunction  

Manufacturer Narrative

The rapid infuser was returned for investigation and was tested using our standard operating procedures.Upon receipt, we found that the computer board was contaminated with saline, which prevented the touch screen from functioning properly.As fluid contamination may damage internal components, the service and preventive maintenance schedule outlined in the operator's manual instructs the user to check the unit seals every six months.The manual provides the following cleaning instructions: "inspect the seal around the unit to make certain it is in good condition.Check also the seal around the touch screen and ceramic disks.Use dow corning 732 multipurpose rtv sealant or equivalent if needed to maintain fluid resistance." the manufacturing records for this serial number were reviewed and nothing notable was observed.There was no patient injury reported.We will continue to monitor for similar reports of this nature.Should additional information become available, a supplemental report will be submitted.

Event Description

The user facility reported that the unit was randomly selecting the pump speed to infuse at 500ml/min by itself without anyone touching the screen.

• 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: 9318276
• MDR Text Key: 197959581
• Report Number: 1219702-2019-00086
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 10/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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