Brand Name | AMIA AUTOMATED PD CYCLER SET |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MOUNTAIN HOME |
1900 n highway 201 |
|
mountain home AR 72653 |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 9546041 |
MDR Text Key | 173561696 |
Report Number | 1416980-2019-07352 |
Device Sequence Number | 1 |
Product Code |
FKX
|
UDI-Device Identifier | 00085412153186 |
UDI-Public | (01)00085412153186 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151525 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/06/2020 |
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 |
Lay User/Patient
|
Device Expiration Date | 01/21/2022 |
Device Catalogue Number | 5C5479 |
Device Lot Number | H19G21018 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/20/2019 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/11/2019 |
Initial Date FDA Received | 01/03/2020 |
Supplement Dates Manufacturer Received | 02/03/2020
|
Supplement Dates FDA Received | 02/06/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | AMIA AUTOMATED PD SYSTEM |