FDA Adverse Event
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 1994410
·
Received February 4, 2011
Report
- Report Number
- 1124841-2011-00061
- Date Received
- February 4, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 2, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS, THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE SHUNT SENSOR LEAKED. THE PRODUCT WAS CHANGED OUT. THERE WAS NO DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS 1CC OF BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | MK13A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |