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

Model Number 814851

Device Problems Charred (1086); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there was a blank screen on the t-link system.The power light emitting diode (led) was on.The device was not changed out, as the customer used paper charting for the case.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.Per the laboratory evaluation, the pc appears to power up normally, except the display (no backlight) never comes on.Discovered a wire that runs to the backlight inverter board was charred and broken.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts nd/or conclusion, a supplemental report will be filed accordingly.

• 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: 4105543
• MDR Text Key: 16303465
• Report Number: 1828100-2014-00782
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• 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: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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