FDA Adverse Event
Other
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1518980
·
Received October 29, 2009
Report
- Report Number
- 1828100-2009-00568
- Event Type
- Other
- Date Received
- October 29, 2009
- Date of Event
- October 5, 2009
- Report Date
- October 29, 2009
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
THE FIELD SERVICE REPRESENTATIVE MADE A REQUEST TO TECHNICAL SUPPORT REGARDING THE LEVEL SENSOR THAT WAS LISTED TO HIM IN THE PARTS DATABASE. FURTHER REVIEW OF THE PARTS RECORD REVEALED THE LEVEL SENSOR WAS MISLABELED. THE PACKAGING AND SHIPPING WORK BOTH DISPLAYED (B) (4), ALTHOUGH (B) (4) WAS STAMPED ON THE PROBE OF THE LEVEL SENSOR. NO ISSUE WAS REPORTED WITH THE ACTUAL FUNCTION OF THE LEVEL SENSOR. THIS REPORT IS BEING SUBMITTED DUE TO THE MISLABELING OF THE LEVEL SENSOR. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | HEART LUNG CONSOLE (LEVEL SENSOR) | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 195274 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |