FDA Adverse Event
Malfunction
Summary report: N
QUADROX-I ADULT + FILTER
MDR report key: 3902824
·
Received February 20, 2014
Report
- Report Number
- 8010762-2014-00060
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 21, 2014
- Report Date
- January 22, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTZ
- PMA / PMN Number
- K100278
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MAQUET MED SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS CLOTTING IN AN OXYGENATOR. PROBLEMS WERE ALSO EXPERIENCED PRIMING THE HEART LUNG UNIT. ACT VALUE WAS OVER 350. COLD ANTIBODIES PLAYED NO ROLE, AS THIS WAS DRIVEN UNDER NORMAL BODY TEMPERATURE. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106983 | QUADROX-I ADULT + FILTER | MICROPOROUS MEMBRANE OXYGENATOR | DTZ | MAQUET CARDIOPULMONARY AG | 70103.1736 | 70094121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |