Brand Name | CLEARLINK/DUO-VENT |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER INTERNATIONAL INC. |
one baxter parkway |
deerfield IL 60015 |
|
MDR Report Key | 7224346 |
MDR Text Key | 98468218 |
Report Number | 7224346 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
12/21/2017,01/08/2018 |
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 |
Nurse
|
Device Model Number | 2H7462 |
Device Catalogue Number | 2H7462 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/21/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/21/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/29/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | IV PUMP: ALARIS PC CAREFUSION MODEL#8015- THE "BRA |
Patient Age | 70 YR |
|
|