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

Model Number DUAL PATIENT LINE

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The dual patient line disposable set was returned to belmont; the investigation is in process and is not yet complete.A visual inspection of the library/retain sample for this lot number was performed and there was no evidence of any defects observed.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All dual patient lines 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.There was no patient injury reported.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Belmont's distributor received a complaint from the user facility stating that there was a leak at the y-connector of the dual patient line.

Manufacturer Narrative

The dual patient line disposable set involved in the incident was returned to belmont for investigation and it was determined that the set was assembled with the incorrect y-connector.The connector had an open center post allowing fluid to pass through, confirming the leak as reported.An inspection of the library/retain sample for this lot number indicated no defect of this nature.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.A review of past complaints indicates that there have been no other reports of this nature, nor any other reports related to this lot number.This appears to be an isolated incident.There was no patient injury reported.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• MDR Report Key: 10220776
• MDR Text Key: 197964255
• Report Number: 1219702-2020-00049
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002053
• UDI-Public: (01)00896128002053(17)220630(10)20191104
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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 Expiration Date: 11/30/2022
• Device Model Number: DUAL PATIENT LINE
• Device Catalogue Number: 903-00004P
• Device Lot Number: 2019-11 04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1