FDA Adverse Event
Malfunction
Summary report: N
01971110 QUADROX-I OXYGENATOR
MDR report key: 3980502
·
Received June 5, 2014
Report
- Report Number
- 8010762-2014-00226
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 6, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTZ
- PMA / PMN Number
- K132829
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE IS CURRENTLY UNDERGOING INVESTIGATION. AN INTERNAL CORRECTIVE ACTION PROCESS HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND APPROPRIATE CORRECTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT 30 MINUTES INTO A PERFUSION RUN, BLOOD LEAKAGE WAS OBSERVED AT THE GAS OUTLET PORT OF THE DEVICE. THE TURN WAS COMPLETED WITH THE DEVICE WITH NO PT EFFECT REPORTED. REF.: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329901 | 01971110 QUADROX-I OXYGENATOR | MICROPOROSE MEMBRANE OXYGENATOR | DTZ | MAQUET CARDIOPULMONARY AG | NI | 70095984 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |