FDA Adverse Event
Malfunction
Summary report: N
HOLLOW FIBER IXY WITH 4000 ML
MDR report key: 4224515
·
Received October 27, 2014
Report
- Report Number
- 1124841-2014-00169
- Event Type
- Malfunction
- Date Received
- October 27, 2014
- Date of Event
- October 1, 2014
- Report Date
- October 9, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- DTZ
- PMA / PMN Number
- K130333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
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 AVAILALBE. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE GAS OUTLET AND SUCTION PORT OF THE OXYGENATOR WERE FOUND BENT. NO PATIENTS INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 684578 | HOLLOW FIBER IXY WITH 4000 ML | BLOOD GAS OXYGENATOR | DTZ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 3CXRX15RW40 | RF16 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |