FDA Adverse Event
Summary report: N
CAPIOX RX OXYGENATOR W/HS RESERVOIR
MDR report key: 2244015
·
Received September 7, 2011
Report
- Report Number
- 1124841-2011-00407
- Date Received
- September 7, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 15, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTZ
- PMA / PMN Number
- K062381
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE, (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THERE WAS A FOREIGN OBJECT INSIDE THE RESERVOIR. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPIOX RX OXYGENATOR W/HS RESERVOIR | BLOOD-GAS OXYGENATOR | DTZ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | NA | NF02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |