FDA Adverse Event
Malfunction
Summary report: N
TERUMO AIR BUBBLE DETECTOR
MDR report key: 930761
·
Received October 17, 2007
Report
- Report Number
- 1828100-2007-00370
- Event Type
- Malfunction
- Date Received
- October 17, 2007
- Date of Event
- September 14, 2007
- Report Date
- October 17, 2007
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- KRL
- PMA / PMN Number
- K935977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION ANTICIPATED BUT NOT BEGUN.
Description of Event or Problem · 1
DURING PREPARATION FOR USE OF THE DEVICE, THE AIR BUBBLE SENSOR DID NOT ALARM WHEN EXPOSED TO AN AIR BUBBLE. 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 AIR BUBBLE DETECTOR | AIR SENSOR | KRL | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 5773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |