Brand Name | SARNS 8000 UNIVERSAL ROLLER PUMP |
Type of Device | PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
6200 jackson road |
ann arbor MI 48103 |
|
MDR Report Key | 8826675 |
MDR Text Key | 152202632 |
Report Number | 1828100-2019-00404 |
Device Sequence Number | 1 |
Product Code |
DWB
|
Combination Product (y/n) | N |
PMA/PMN Number | K953901 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup,Followup |
Report Date |
10/22/2019 |
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 | 16402 |
Device Catalogue Number | 16402 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/02/2019 |
Initial Date FDA Received | 07/25/2019 |
Supplement Dates Manufacturer Received | 08/21/2019 10/22/2019
|
Supplement Dates FDA Received | 09/12/2019 10/22/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|