MAUDE Adverse Event Report: BELMONT INSTRUMENT CORP. BELMONT RAPID INFUSER; WARMER, THERMAL, INFUSION FLUID

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Loss of Power (1475); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 01/17/2018

Event Type  Death  

Event Description

Belmont rapid infuser was intermittently being used and rates were alternating between 50 and 500ml.Approximately 1.5 hours later, the belmont shut off on its own accord several times.Each time the unit was rebooted and functioned correctly for a few minutes.The last time it powered off on its own, and was rebooted, the machine gave the error message "temperature overheat" in a large box in the upper right hand corner, followed by "change disposable" in smaller wording underneath., another belmont unit was obtained along with new disposables, disposables loaded and machine turned on.Immediately the 2nd machine gave the error code of "temperature overheat".When the cartridge door was opened to remove the disposable, a distinct burning smell could be detected and the heat exchanger ring was burnt at the "5-7 o'clock" position.A 3rd unit was obtained, new disposables were loaded and the same exact error message appeared (neither machine #2 nor #3 could complete their self tests).The 3rd machine was taken into a different operating room, and unit powered on without incident.The disposables were primed and machine operated appropriately.

• Brand Name: BELMONT RAPID INFUSER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT INSTRUMENT CORP.; boston MA 01821
• MDR Report Key: 7211886
• MDR Text Key: 98068184
• Report Number: MW5074698
• Device Sequence Number: 2
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death