FDA Adverse Event
Death
Summary report: N
3/8" X 3/32" ULTRASONIC AIR SENSOR
MDR report key: 487297
·
Received September 30, 2003
Report
- Report Number
- 1828100-2003-00007
- Event Type
- Death
- Date Received
- September 30, 2003
- Date of Event
- March 17, 2003
- Report Date
- September 30, 2003
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
MANUFACTURER RECEIVED A COMPLAINT INDICATING THE PT DIED OF AIR EMBOLISM THAT OCCURRED DURING CARDIOPULMONARY BYPASS. NO PREVIOUS NOTIFICATION OR COMPLAINT WAS RECEIVED FROM THE HOSPITAL OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3/8" X 3/32" ULTRASONIC AIR SENSOR | AIR SENSOR | DTQ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 98-0702-0842-0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death |