MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-11-30 for ROTAFLOW CENTRIFUGAL PUMP SYSTEM ROTAFLOW ENGLISH/UK UK-PLUG ICU 70105.1697 manufactured by Maquet Cardiopulmonary Gmbh.
| Report Number | 8010762-2019-00374 |
| MDR Report Key | 9392251 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-11-30 |
| Date of Report | 2019-11-28 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2019-11-15 |
| Device Manufacturer Date | 2018-11-09 |
| Date Added to Maude | 2019-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | NURSEL BOELENS |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTAFLOW CENTRIFUGAL PUMP SYSTEM |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | DTQ |
| Date Received | 2019-11-30 |
| Model Number | ROTAFLOW ENGLISH/UK UK-PLUG ICU |
| Catalog Number | 70105.1697 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY GMBH |
| Manufacturer Address | NEUE ROTTENBURGER STRASSE 37 HECHINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-30 |