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 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

The 3-spike disposable set was discarded at the hospital and was not available for investigation.Upon reviewing photographs provided by the user facility, we were able to confirm that there was a leak near the heat exchanger; however, it is difficult to determine the root cause of the leak without investigating the set.A visual inspection of the library/retain sample for this lot number was performed and no evidence of any defects was observed.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All 3-spike disposable sets are 100% leak tested prior to release from belmont medical technologies.A review of past complaints indicates that there have been no additional leaks reported with this lot number.It was reported that there was no injury to the patient.Should additional information become available, a supplemental report will be submitted.

Event Description

Belmont's distributor received a complaint from the user facility stating that the 3-spike disposable set had a leak between the bottom of the heat exchanger and the tubing.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 10171875
• MDR Text Key: 197963827
• Report Number: 1219702-2020-00047
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: (01)00896128002022(17)220630(10)20191106
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Device Lot Number: 2019-11 06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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