FDA Adverse Event
Malfunction
Summary report: N
T-LINK DATA MANAGEMENT SYSTEM
MDR report key: 2052062
·
Received March 1, 2011
Report
- Report Number
- 1828100-2011-00493
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- February 7, 2011
- Report Date
- March 1, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DWA
- PMA / PMN Number
- K950739
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE SOFTWARE APPLICATION REVERTED TO THE TRIAL VERSION AFTER AN EXCHANGE OF WIRELESS ADAPTER CARDS. THE DEVICE WAS NOT CHANGED OUT FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T-LINK DATA MANAGEMENT SYSTEM | PERFUSION LIBRARY SOFTWARE | DWA | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 814850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |