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

Model Number 3-SPIKE DISPOSABLE SET

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The 3-spike disposable set involved in the incident was discarded at the hospital and was, therefore, not available for investigation.A review of the photographs provided by the user facility indicate evidence of potential residual adhesive in the tubing of the 3-spike disposable set.However, the photographs are not detailed enough to determine the actual condition of the tubing.A review of a specific library/retain sample and batch record information is not possible, as it was reported that the lot number of the 3-spike in question is unknown.All 3-spike sets are 100% leak tested and 100% visually inspected during the manufacturing process.The user facility reported that a large bore arrow mac sheath was used to administer cell saver blood.The operator's manual instructs the user: "select an appropriate cannula size for the decided flow rate" and provides the following guide: "match the infusion set to flow rate and fluid type", which contains a chart to help the user choose an appropriate cannula size for their desired flow rate and infusate.The manual also cautions the user: "a single dedicated intravenous access should be used exclusively for infusing blood components and solutions compatible with blood." it was reported that the leak wasn't noted until the set was being disassembled; no patient injury was reported.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's distributor received a complaint involving a 3-spike disposable set from the user facility, and relayed the following report: "the belmont set was primed around 11:00 am on 21 august.It was used from around 11:30 to 12:30 to administer around 2 litres of products including cell saver blood through a large bore arrow mac sheath.When we were disassembling it we noticed a small amount of red blood inside the door.Debbie (anaesthetic nurse) and i examined the set and found a leak between the heating coil and the line (refer to photos attached).It was very small.The line could be easily pulled apart.".

• 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: 10589727
• MDR Text Key: 208637055
• Report Number: 1219702-2020-00075
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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