FDA Adverse Event
Summary report: N
CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR
MDR report key: 2012208
·
Received February 25, 2011
Report
- Report Number
- 1124841-2011-00112
- Date Received
- February 25, 2011
- Date of Event
- January 17, 2011
- Report Date
- February 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTZ
- PMA / PMN Number
- K993772
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT REC'D 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 OXYGENATOR LEAKED. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR | BLOOD-GAS OXYGENATOR | DTZ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | MN01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |