FDA Adverse Event
Malfunction
Summary report: N
QUADROX-I ADULT WITHOUT FILTER
MDR report key: 3862172
·
Received March 4, 2014
Report
- Report Number
- 8010762-2014-00222
- Event Type
- Malfunction
- Date Received
- March 4, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 4, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTZ
- PMA / PMN Number
- K090511
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDED PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. DEVICE INVESTIGATION IS STILL UNDER PROGRESS TO DETERMINE THE ROOT-CAUSE AND FURTHER CORRECTIVE ACTIONS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PRIMING, LEAKAGE OCCURRED AT TUBE LINE. REF.: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130024 | QUADROX-I ADULT WITHOUT FILTER | MICROPROSE MEMBRANE OXYGENATOR | DTZ | MAQUET CARDIOPULMONARY AG | 70103.2230 | 70093386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |