Brand Name | HOMECHOICE PRO |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
BAXTER HEALTHCARE - SINGAPORE |
2 woodlands industrial park |
singapore 2573 |
SN 2573 |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - SINGAPORE |
2 woodlands industrial park |
|
singapore 2573 |
SN
2573
|
|
Manufacturer Contact |
christina
arnt
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242703198
|
|
MDR Report Key | 3585788 |
MDR Text Key | 4188335 |
Report Number | 1416980-2014-02291 |
Device Sequence Number | 1 |
Product Code |
FKX
|
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 |
12/27/2013 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 5C8310R |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/17/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/05/2014 |
Initial Date FDA Received | 01/21/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/03/2014
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | DIANEAL PD4, 2.5% AMBUFLEX |
Patient Outcome(s) |
Death;
|
Patient Age | 59 YR |