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 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

The disposable sets have not been returned for investigation.The manufacturing records of the associated lot were reviewed and nothing notable was observed.All 3-spike disposable sets are 100% leak tested prior to release.We have not received any additional complaints about this lot.We will continue to follow up with the customer to obtain additional information about the case.There was no patient injury reported.Without additional information, it is difficult to determine what occurred in this case.This appears to be an isolated incident; should additional information become available, a supplemental report will be provided.We will continue to monitor and trend similar reports of this nature.

Event Description

Our distributor received a complaint from the user facility and reported that the customer experienced two breaks with two 3-spike disposable sets, which subsequently leaked at the output temperature probes.

• 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: 8899404
• MDR Text Key: 195273001
• Report Number: 1219702-2019-00055
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Device Lot Number: 2018-08 02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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