FDA Adverse Event
Summary report: N
CAPIOX FX OXYGENATOR
MDR report key: 2030147
·
Received March 16, 2011
Report
- Report Number
- 9681834-2011-00010
- Date Received
- March 16, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 3, 2011
- Manufacturer
- TERUMO CORP
- Product Code
- DTZ
- PMA / PMN Number
- K071494
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION; THEREFORE, TERUMO IS STILL INVESTIGATING THIS ISSUE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION 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 GAS EXCHANGE SEEMED UNSTABLE. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PATIENT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPIOX FX OXYGENATOR | BLOOD-GAS OXYGENATOR | DTZ | TERUMO CORP | 1CX*FX25RX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |