MAUDE Adverse Event Report: TERUMO BCT EUROPE N.V. T-SEAL II; ME-TSEAL2 TUBE SEALING DEVICE 100-240V

Model Number 2METSEAL2

Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that while sealing tubing, there was a "flame" coming from the bottom of the sealer device.The device has been taken out of use.No patient or donor was present or connected at the time of the event, and the condition of the operator of the device is not known at this time.The patient (operator) information is not available at this time.Terumo bct (b)(4) is awaiting return of the device for evaluation.

Manufacturer Narrative

The device was returned to terumo bct (b)(4) for evaluation.Upon visual inspection, wear was noted on the moving electrode with missing plating.Damage was also observed on the sealing rim and blood was noted on both the fixed and moving electrodes.It was also noted that the device had burn marks originating from the outside of the device.There was no indication of burns on the inside of the device.Twenty welds were performed with the device and the seals were normal.The device is functioning correctly.The manufacturing records were reviewed.No abnormalities were noted in the records that would have contributed to the issue.Root cause: the root cause of this failure is undetermined.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: terumo bct leuven informed the customer with the evaluation results of the returned device.However, the customer declined repair and requested for the device to be returned to the customer's site.Terumo bct leuven initiated an internal capa for the reported condition.

Event Description

Due to eu personal data protection laws, the patient (operator) information and outcome are not available from the customer.

• Brand Name: T-SEAL II
• Type of Device: ME-TSEAL2 TUBE SEALING DEVICE 100-240V
• Manufacturer (Section D): TERUMO BCT EUROPE N.V.; leuven vlaams brabant ; BE
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6191170
• MDR Text Key: 63296047
• Report Number: 1722028-2016-00658
• Device Sequence Number: 1
• Product Code: KSD
• Combination Product (y/n): N
• Reporter Country Code: AL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2METSEAL2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/01/2016
• Event Location: Other
• Date Report to Manufacturer: 12/20/2016
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other