Brand Name | CBCII CONSTAVAC |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
3T MEDICAL SYSTEMS, INC. |
41157 capital drive |
canton MI 48187 |
|
MDR Report Key | 10689638 |
MDR Text Key | 211665845 |
Report Number | 10689638 |
Device Sequence Number | 1 |
Product Code |
CAC
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/28/2020,09/22/2020 |
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 | 225-028-000E |
Device Catalogue Number | 225-028-000E |
Device Lot Number | 19071201M |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/28/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/16/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/16/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 21170 DA |
|
|