FDA Adverse Event
Malfunction
Summary report: N
SX OXYGENATOR W/HR X COATING
MDR report key: 4102324
·
Received August 27, 2014
Report
- Report Number
- 1124841-2014-00133
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Report Date
- August 14, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTZ
- PMA / PMN Number
- K130359
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCED EVALUATION CONCLUSION. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING CARDIOPULMONARY BYPASS BLOOD LEAKED FROM THE EXHAUST PORT OF THE OXYGENATOR. 20-30 ML BLOOD LOSS. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522662 | SX OXYGENATOR W/HR X COATING | BLOOD GAS OXYGENATOR | DTZ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 3CXSX18RX | RG02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |