FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 1893037
·
Received November 2, 2010
Report
- Report Number
- 1828100-2010-01961
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- August 9, 2010
- Report Date
- November 2, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER OBSERVED ERROR CODES F133, F033, AND F233. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CDI 500 BLOOD PARAMETER MONITOR | ON LINE BLOOD GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 500AVHCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |