FDA Adverse Event
Injury
Summary report: N
HLS-SET OR PLS -SET
MDR report key: 4276152
·
Received November 18, 2014
Report
- Report Number
- 8010762-2014-01230
- Event Type
- Injury
- Date Received
- November 18, 2014
- Report Date
- October 29, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVAL. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THREE PTS DEVELOPED PARALYSIS DURING IABP (INTRA-AORTIC BALLOON PUMP) AND ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION) COMBINED. THIS IS PT 2 OF 3, REFER TO MFG REPORT # 8010762-2014-01229 AND 8010762-2014-01231 FOR THE OTHER TWO PTS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745732 | HLS-SET OR PLS -SET | NONE | DTQ | MAQUET CARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |