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 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
douglas
patton
|
6200 jackson road |
ann arbor, MI 48103
|
7346634145
|
|
MDR Report Key | 13589017 |
MDR Text Key | 286049937 |
Report Number | 1828100-2022-00072 |
Device Sequence Number | 1 |
Product Code |
KFM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K902198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/16/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 9490 |
Device Catalogue Number | 9490 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/01/2022 |
Initial Date FDA Received | 02/23/2022 |
Supplement Dates Manufacturer Received | 02/22/2022
|
Supplement Dates FDA Received | 03/16/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/12/1999 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|