Brand Name | HOMECHOICE AUTOMATED PD SET WITH CASSETTE |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
carretera sanchez km 18.5 |
parque industrial itabo, piisa |
haina, san cristobal 91000 |
DR
91000
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 16363782 |
MDR Text Key | 309403451 |
Report Number | 1416980-2023-00445 |
Device Sequence Number | 1 |
Product Code |
FKX
|
UDI-Device Identifier | 00085412090078 |
UDI-Public | (01)00085412090078 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102936 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
03/14/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | L5C4531 |
Device Lot Number | H22E20126 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/19/2023 |
Initial Date FDA Received | 02/13/2023 |
Supplement Dates Manufacturer Received | 02/20/2023
|
Supplement Dates FDA Received | 03/14/2023
|
Date Device Manufactured | 05/20/2022 |
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 | CYCLER |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 74 YR |
Patient Sex | Female |
|
|