Brand Name | CADD-LEGACY® PCA PUMP |
Type of Device | PUMP, INFUSION, ENTERAL |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7325513 |
MDR Text Key | 101979693 |
Report Number | 3012307300-2018-00515 |
Device Sequence Number | 1 |
Product Code |
LZH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/08/2018 |
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 | 1400 |
Device Catalogue Number | 21-1400-02 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/20/2017 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/13/2018 |
Initial Date FDA Received | 03/08/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/22/2015 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|