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

Model Number 3-SPIKE DISPOSABLE SET

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

The 3-spike disposable set involved in the incident was not available for investigation.Upon follow up with the user facility, it was reported that the issue was determined to be provider error, and not the result of any potential malfunction.Following the incident, belmont's clinical specialist followed up with the user facility via telephone, and learned that the leak was caused by the connection between the hub of the catheter, and the patient line not being turned tightly enough.The user stated that this was an isolated incident.Belmont's clinical specialist offered additional training to the user facility.It was reported that the belmont rapid infuser was operating as intended, and was subsequently used in trauma cases with no further issues.The manufacturing batch records for this lot were reviewed, and no anomalies were identified.All 3-spike disposable sets are 100% leak tested, and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that there have been no other complaints related to this lot number.We will continue to monitor and trend similar reports of this nature, and take further action if required.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont received a medwatch report (uf/importer report # (b)(4)) from the department of health & human services, about an event that reportedly occurred in july 2020, "had mtp infusion in trauma room on traumatic hypotensive patient using belmont infuser.While packaging patient to go to the or, blood was infused using 500 ml pressure bag by removing rapid infuser blood tubing from the belmont machine as the belmont machine was unplugged for transport to or.En-route to or, belmont tubing connection pulled apart resulting in loss of approximately 100 ml whole blood.After incident and briefing, new belmont blood tubing was opened in new packaging and connection found to be loose upon opening package.Educator made aware of incident.".

Event Description

Belmont received a medwatch report (uf/importer report # (b)(4)) from the department of health & human services, about an event that reportedly occurred in (b)(6) 2020: "had mtp infusion in trauma room on traumatic hypotensive patient using belmont infuser.While packaging patient to go to the or, blood was infused using 500 ml pressure bag by removing rapid infuser blood tubing from the belmont machine as the belmont machine was unplugged for transport to or.Enroute to or, belmont tubing connection pulled apart resulting in loss of approximately 100 ml whole blood.After incident and briefing, new belmont blood tubing was opened in new packaging and connection found to be loose upon opening package.Educator made aware of incident.".

• 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
• MDR Report Key: 10659473
• MDR Text Key: 210857421
• Report Number: 1219702-2020-00083
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: (01)00896128002022(17)230531(10)20200503
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Device Lot Number: 2020-05 03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR