FDA Adverse Event
Other
Summary report: N
SHUNT SENSOR SYS500
MDR report key: 1916581
·
Received November 30, 2010
Report
- Report Number
- 1124841-2010-00216
- Event Type
- Other
- Date Received
- November 30, 2010
- Date of Event
- November 9, 2010
- Report Date
- November 10, 2010
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT YET REC'D THE ACTUAL DEVICE, AND WILL BE SUBMITTING A F/U REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (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 NOT CHANGED OUT. THERE WAS A MINIMAL AMOUNT OF BLOOD LOSS. THE SURGERY WAS NOT DELAYED AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHUNT SENSOR SYS500 | BLOOD-GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CDI510H | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |