Brand Name | CADD SOLIS AMBULATORY INFUSION PUMP |
Type of Device | MEA - PUMP, INFUSION, PCA |
Manufacturer (Section D) |
SMITHS MEDICAL |
st. paul MN |
|
Manufacturer Contact |
pete
hirte
|
1265 grey fox rd. |
st. paul, MN 55112
|
6516287384
|
|
MDR Report Key | 4012673 |
MDR Text Key | 16085436 |
Report Number | 2183502-2014-00481 |
Device Sequence Number | 1 |
Product Code |
MEA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K072144 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
07/08/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/08/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 21-2111 |
Device Catalogue Number | 21-2111-0100-51 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 06/16/2014 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/08/2014 |
Device Age | 1 YR |
Event Location |
Hospital
|
Date Manufacturer Received | 06/13/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2013 |
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 |
|
|