Brand Name | CADD LEGACY 6400 |
Type of Device | PUMP, INFUSION |
Manufacturer (Section D) |
SMITHS MEDICAL ASD,INC |
6000 nathan lane |
minneapolis, mn |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
5700 west 23rd avenue, |
|
gary,, in |
|
Manufacturer Contact |
dave
halverson
|
6000 lane n |
minneapolis, mn
|
3833310
|
|
MDR Report Key | 9772606 |
MDR Text Key | 181535510 |
Report Number | 3012307300-2020-01641 |
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,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/29/2020 |
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 |
No Information
|
Device Model Number | 6400 |
Device Catalogue Number | 21-6400-51 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/04/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/03/2020 |
Initial Date FDA Received | 02/29/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/22/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|