MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for SARNS CENTRIFUGAL SYSTEM 6379 manufactured by Terumo Cardiovascular Systems Corporation.
Report Number | 1828100-2020-00145 |
MDR Report Key | 9908689 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-03-31 |
Date of Report | 2020-04-01 |
Date of Event | 2020-03-11 |
Date Mfgr Received | 2020-03-11 |
Device Manufacturer Date | 2009-11-19 |
Date Added to Maude | 2020-03-31 |
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 | BIOMEDICAL ENGINEER |
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 | 3 |
Brand Name | SARNS CENTRIFUGAL SYSTEM |
Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM |
Product Code | DWA |
Date Received | 2020-03-31 |
Model Number | 6379 |
Catalog Number | 6379 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
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 | 2020-03-31 |