FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1032190
·
Received April 21, 2008
Report
- Report Number
- 1828100-2008-00221
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- March 26, 2008
- Report Date
- April 21, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- PMA / PMN Number
- K022947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION FOR USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE SENSOR DID NOT FUNCTION AS EXPECTED. THERE WAS NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO ADVANCED PERFUSION SYSTEM 1 | AIR BUBBLE DETECTOR MODULE | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 802110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |