FDA Adverse Event
Other
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 1914417
·
Received November 16, 2010
Report
- Report Number
- 1828100-2010-02140
- Event Type
- Other
- Date Received
- November 16, 2010
- Date of Event
- October 14, 2010
- Report Date
- November 16, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE BLOOD PARAMETER PROBE HAD A BROKEN THERMISTOR. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE 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 | BLOOD PARAMETER MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 145891 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |