FDA Adverse Event
Malfunction
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 2904119
·
Received January 3, 2013
Report
- Report Number
- 1124841-2013-00014
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 13, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS NOT BEEN COMPLETED. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT, DURING CARDIOPULMONARY BYPASS, THE SHUNT SENSOR LEAKED. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO KNOWN IMPACT OR CONSEQUENCE TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2334 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP | CDI510H | PK13F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |