MAUDE Adverse Event Report: BELMONT INSTRUMENT CORPORATION THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number FMS2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 04/10/2015

Event Type  malfunction  

Manufacturer Narrative

Belmont immediately responded to the report of this incident by meeting with the facility in order to understand the nature of the event.The team at the facility first explained that they had a number of events in which there was a marked drop in blood pressure while rapidly infusing into a patient.The possibility that bradykinins were being generated by a visual change to the filter support was raised.Belmont explained that while the filter did indeed look different, the materials were all the very same class vi materials that had been utilized in the system since its initial release in 1997; the change was simply of geometry and the filter material was exactly the same as it has always been.Belmont contracted with an independent laboratory to run specific tests in order to determine whether our system could cause the generation of bradykinins.The test results revealed that there is no greater generation of bradykinins with the new reservoir compared with the old reservoir.The bolus feature is a temporary increase in flow rate for a specific volume.The significance of this is that all of the events appear when there is a high rate of infusion, suggesting that the key is the infusate.Single-use disposable device.

Event Description

The report from the user facility describes an event in which saline and a number of blood products were being introduced into a patient in response to surgery-induced hypovolemia at a rate of 500 ml/min.After 500 to 1000 ml of products were infused, the patient began to experience tachycardia and a drop in blood pressure, which were managed with pressors.The system was prophylactically replaced and a similar event occurred subsequently 4 hours later during a bolus operation of the replacement system.This was the first incident where a bolusing of blood products was noticed to cause a hypotensive event.Following this event, there were 4 similar cases.It was noted that of the 5 cases, a total of 4 patients were receiving ace inhibitors.It was also noted that the reservoir filter assembly had been redesigned the previous year.Belmont engineering responded to the initial inquiry by meeting with the hospital personnel in order to understand the situation.The hospital personnel speculated that the change in the filter might be causing the generation of bradykinins in the blood.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT CORPORATION; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT INSTRUMENT CORPORATION; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 5098666
• MDR Text Key: 26618440
• Report Number: 1219702-2015-00001
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002008
• UDI-Public: 00896128002008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: FMS2000
• Device Catalogue Number: 903-00018P
• Device Lot Number: 2015-04 01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 115