FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1213665
·
Received October 24, 2008
Report
- Report Number
- 1828100-2008-00546
- Event Type
- Malfunction
- Date Received
- October 24, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 23, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING A USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CENTRAL CONTROL MONITOR OF THE HEART LUNG CONSOLE TURNED PURPLE, PINK, BLUE AND BLACK THEN WENT BACK TO NORMAL COLOR. THE SCREEN DID NOT BLANK OUT AND THE ABILITY TO USE THE SCREEN WITH THIS FAILURE WOULD NOT IMPAIR ITS FUNCTIONALITY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE (MONITOR) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |