Brand Name | CADD LEGACY PUMP |
Type of Device | PUMP, INFUSION |
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 north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 9537104 |
MDR Text Key | 173387028 |
Report Number | 3012307300-2019-07566 |
Device Sequence Number | 1 |
Product Code |
FRN
|
UDI-Device Identifier | 10610586019548 |
UDI-Public | 10610586019548 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K982838 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/31/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 6400 |
Device Catalogue Number | 21-6400-51 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/05/2019 |
Initial Date FDA Received | 12/31/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/28/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 39 YR |
Patient Weight | 80 |
|
|