MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-28 for HLM TUBING SET W/BIOLINE COATING manufactured by Maquet Cardiopulmonary Gmbh.
| Report Number | 3008355164-2019-00014 |
| MDR Report Key | 8939160 |
| Date Received | 2019-08-28 |
| Date of Report | 2019-09-30 |
| Date of Event | 2019-08-05 |
| Date Facility Aware | 2019-09-20 |
| Report Date | 2019-09-30 |
| Date Reported to FDA | 2019-09-30 |
| Date Reported to Mfgr | 2019-09-30 |
| Date Added to Maude | 2019-08-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HLM TUBING SET W/BIOLINE COATING |
| Generic Name | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Product Code | DWE |
| Date Received | 2019-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Life Threatening | 2019-08-28 |