MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. T-LINK DATA MANAGEMENT SYSTEM

Model Number 814851

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the perfusionist (ccp) smelled something burning.The scrub tech thought they saw a haze near the unit.As a result, an alternate system was employed.The surgical procedure ws completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.

Manufacturer Narrative

Eval is in progress, but not yet concluded.The user facility's biomedical engineer (biomed) looked at the unit and he observed the upper work holes had an electronic "burnt silicone" smell.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.Evaluation of the device found that upon startup, there was a burning smell coming from the monitor.The unit powered up and functioned normally.A coil on the internal power supply was charred, causing the burnt smell, but there was no loss of function.No additional action will be taken at this time.

Manufacturer Narrative

The suspect device was sent to the supplier for further evaluation.They performed a couple of burn-in tests for about two hours, running for a few days, in order to test the unit in full capacity under room temperature.Unit was working properly.They removed the back cover and inspected the unit and did not see any burnt components.They looked at the coil inside the power supply and found that it was chipping.Since this power supply is purchased from a third party vendor, they reviewed the flammability rating and found that it would not cause any hazards or fire.This power supply meets the standard safety regulations underwriters laboratories (ul) 1950.They further investigated and looked at their past records for this specific product and found no similar cases.This is considered an isolated occurrence.

• Brand Name: T-LINK DATA MANAGEMENT SYSTEM
• Type of Device: T-LINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4745307
• MDR Text Key: 5772302
• Report Number: 1828100-2015-00346
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 814851
• Device Catalogue Number: 814851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1