Brand Name | SARNS DELPHIN BASE ADAPTER WITH BATTERY |
Type of Device | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE- SARNS CENTRIFUGAL SYSTEM |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
6200 jackson road |
ann arbor MI 48103 |
|
MDR Report Key | 9405271 |
MDR Text Key | 199263224 |
Report Number | 1828100-2019-00642 |
Device Sequence Number | 1 |
Product Code |
KFM
|
Combination Product (y/n) | N |
PMA/PMN Number | K902198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial,Followup |
Report Date |
01/13/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/03/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 9490 |
Device Catalogue Number | 9490 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/08/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | 1828100-06/29/12-020-C |
Patient Sequence Number | 1 |
|
|