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 | 16541747 |
MDR Text Key | 311485788 |
Report Number | 1416980-2023-01077 |
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 |
Consumer,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/13/2023 |
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 Catalogue Number | 5C5479 |
Device Lot Number | H22K29050 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/07/2023 |
Initial Date Manufacturer Received |
02/16/2023 |
Initial Date FDA Received | 03/14/2023 |
Supplement Dates Manufacturer Received | 04/10/2023
|
Supplement Dates FDA Received | 04/13/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/29/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | AMIA AUTOMATED PD SYSTEM; UNSPECIFIED SOLUTION |