FDA Adverse Event
Malfunction
Summary report: N
TERUMO ADVANCED PERFUSION SYSTEM 1
MDR report key: 1002086
·
Received February 20, 2008
Report
- Report Number
- 1828100-2008-00102
- Event Type
- Malfunction
- Date Received
- February 20, 2008
- Date of Event
- January 19, 2008
- Report Date
- February 20, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- KRL
- PMA / PMN Number
- K940651
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS BUT NOT CONCLUDED.
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE AIR BUBBLE DETECTION SYSTEM CONTINUALLY ALARMED. THERE WAS NO ADVERSE CONSEQUENCE 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 | KRL | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 5773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |