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

Model Number 3-SPIKE DISPOSABLE SET

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that two 3-spike disposable sets loaded into a rapid infuser, ri-2 began leaking during a massive transfusion case.The 3-spike disposable sets involved in the incident have not yet been returned to belmont for investigation.Belmont's sales representative followed up with the hospital and arranged for return of the disposable sets and associated rapid infuser to determine whether there are any anomalies with the devices.A review of the photographs provided by the user facility indicates a separation of the nozzle at the heat exchanger.The manufacturing batch records for the reported lot number were reviewed and no anomalies were identified.There have been no other complaints related to this lot number.A review of complaints for the past three years indicates that this is an isolated incident; there have been no other reports of this nature related to the 3-spike disposable set.No patient injury was reported, however it was reported that there was a delay in care due to the reported product problem.Belmont will continue working closely with the hospital and actively investigating to establish a root cause.A follow-up report will be submitted once the devices have been returned for investigation and additional information becomes available.

Event Description

Belmont medical technologies received a report from the user facility on june 17, 2021 that a part of the plastic broke above the heat exchanger on two 3-spike disposable sets.On june 26, belmont subsequently received user facility report number (b)(4) from the fda, with the following event description: "initiated massive transfusion using belmont rapid infuser ri-2 to a trauma patient.Noted blood leaking out of side of the rapid infuser machine and when the door of rapid infuser was opened, blood was seen to be leaking at a connection near the circle.It was noted that the tubing was correctly loaded.Obtained second set of tubing which was loaded into a different belmont rapid infuser machine and primed tubing with saline.When starting to infuse blood, team member noted saline to be leaking from side of rapid infuser machine again.Tubing was observed to be leaking at the same place near a connection by the circle as the first set of tubing.Unfortunately, team member was unable to get the packaging for the tubing as housekeeping was very efficient and had taken the garbage with the tubing package away already.Lot number of tubing in same cabinet is 2021-0308.Thankfully patient was stable as this time and did delay care for approximately 10 minutes as patient did not receive blood during the time of priming tubing and finally needing to use a regular blood tubing with a pressure bag.One of the two disposable tubing was saved and we have contacted a representative of the company to pick up the tubing at our facility.Photos were taken and emailed to the company representative.".

• 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: 12143947
• MDR Text Key: 261975505
• Report Number: 1219702-2021-00088
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: (01)00896128002022(17)240331(10)20210308
• 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: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/09/2021

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 Expiration Date: 03/31/2024
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Device Lot Number: 2021-03 08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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