Brand Name | CADD SOLIS HPCA PUMP |
Type of Device | PUMP, INFUSION, PCA |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan ln n |
minneapolis MN 55442 |
|
Manufacturer Contact |
reed
covert
|
6000 nathan ln n |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 19195145 |
MDR Text Key | 341374364 |
Report Number | 3012307300-2024-03089 |
Device Sequence Number | 1 |
Product Code |
MEA
|
UDI-Device Identifier | 10610586038778 |
UDI-Public | (01)10610586038778(11)160107(21)1097547 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130394 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/19/2024 |
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 | 2110 |
Device Catalogue Number | 21-2111-0300-01 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 04/10/2024 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/27/2024 |
Initial Date FDA Received | 04/26/2024 |
Supplement Dates Manufacturer Received | 05/21/2024
|
Supplement Dates FDA Received | 06/19/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/07/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|