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

Model Number RI-2

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

The unit was returned and was tested using our standard operating procedures.Upon receipt, it was determined that the membrane switch intermittently shorted due to saline and blood contamination on the display.In addition, it was also noted upon receipt that the pole clamp release handle was missing, it was evident that the unit had been opened by the customer, and there appeared to be a dent on the membrane switch.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 indicated.The unit had not been returned to belmont since it was initially shipped to the customer in 2016.There was no patient injury reported.Should additional information become available, a supplemental report will be submitted accordingly.

Event Description

Our distributor received a complaint from the user facility and relayed the following report: "this ri-2 was used during patient case.Flow rate changed without touching the screen from 50 to 60 ml/min and from 60 to 50 ml/min.".

• 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: 8899003
• MDR Text Key: 196269648
• Report Number: 1219702-2019-00054
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 20896128002774
• UDI-Public: (01)20896128002774
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2019

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: 903-00039A-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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