FDA Adverse Event
Injury
Summary report: N
QUADROX ID
MDR report key: 4212932
·
Received October 24, 2014
Report
- Report Number
- 2248146-2014-00447
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 26, 2014
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DTZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. THIS EVENT WAS PREVIOUSLY REPORTED MFR REPORT #: 8010762-2014-00754/IMPORTER REPORT #: (B)(4). EVAL OF THE RETURNED DEVICE DETERMINED (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT EXTRACORPOREAL CIRCULATION WAS INITIATED WITHIN SEVERAL MINUTES BLOOD WAS LEAKING FORM THE BOTTOM OF THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678570 | QUADROX ID | CARDIOPULMONARY | DTZ | DATASCOPE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |