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 Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The 3-spike disposable set involved in the incident was not available for investigation, nor was the lot number available, therefore, review of a specific library/retain sample and batch record information is not possible at this time.Without the sample, or a lot number to evaluate, a root cause cannot be determined.No patient injury was reported.All 3-spike disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.Following receipt of the complaint, belmont contacted the distributor to obtain further information about the case, and to discuss proper spiking techniques.Additional testing has been performed to ensure that the leak test challenges the bond of the tubing to the spike.Belmont 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 report from the user facility that two spikes disconnected from the tubing of a 3-spike disposable set, resulting in a large spill of blood in the ct scanner room.

• 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: 10880229
• MDR Text Key: 217677288
• Report Number: 1219702-2020-00105
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2020

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 Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/20/2020
• 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