MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-17 for SARNS 8000 MODULE PERFUSION SYSTEM 5773 manufactured by Terumo Cardiovascular Systems Corporation.
Report Number | 1828100-2019-00315 |
MDR Report Key | 8704861 |
Date Received | 2019-06-17 |
Date of Report | 2019-06-17 |
Date Mfgr Received | 2019-05-23 |
Device Manufacturer Date | 2010-09-17 |
Date Added to Maude | 2019-06-17 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. DOUGLAS PATTON |
Manufacturer Street | 6200 JACKSON ROAD |
Manufacturer City | ANN ARBOR MI 48103 |
Manufacturer Country | US |
Manufacturer Postal | 48103 |
Manufacturer Phone | 7346634145 |
Manufacturer G1 | SAME |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | SARNS 8000 MODULE PERFUSION SYSTEM |
Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-BUBBLE DETECTOR |
Product Code | KRL |
Date Received | 2019-06-17 |
Model Number | 5773 |
Catalog Number | 5773 |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-17 |