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 Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

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.Belmont medical technologies requested the lot number of the set, as well as return of the set for investigation.The distributor subsequently confirmed that the lot number of the product in question is unknown and that the product is not available to be returned to belmont medical technologies for review.A review of a specific library/retain sample and batch record information is not possible at this time, as the lot number of the item involved has not been provided.A review was conducted to determine which lot numbers have been shipped to the distributor and could therefore potentially represent the product with which the incident occurred, and the batch records and retain samples for those lots were reviewed.All 3-spike sets are 100% leak tested and 100% visually inspected during the manufacturing process.No manufacturing issues were noted in review of the batch records, and additionally, no defects were noted upon review of the retain samples.A review of complaints for the past three years indicates that this was an isolated incident.It was reported that there was no harm to the patient.We will continue to monitor and trend similar reports of this nature and take further action if required.

Event Description

Belmont's distributor received a complaint from the user facility and relayed the following report: "inselspital bern reports that the 3-spike of the thorns broke off while changing the infusion bag." the distributor further detailed that "no harm has come to the patient.".

• 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: 10411059
• MDR Text Key: 205688083
• Report Number: 1219702-2020-00059
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: 00896128002022
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K091855
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 07/15/2020
• 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