FDA Adverse Event
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 2222781
·
Received August 9, 2011
Report
- Report Number
- 1124841-2011-00348
- Date Received
- August 9, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 21, 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
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U 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 SYS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THERE WAS NO GAS FLOW THROUGH THE SHUNT SENSOR. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SET-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | NC19 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |