Brand Name | PLIBERTY CYCLER SET, DUAL PATIENT CONNECT |
Manufacturer (Section D) |
FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING |
reynosa |
MX |
|
Manufacturer Contact |
tanya
taft, rn, cnor
|
920 winter st |
waltham, MA 02451
|
8006621237
|
|
MDR Report Key | 4780574 |
MDR Text Key | 20755324 |
Report Number | 8030665-2015-00249 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
PMA/PMN Number | K043363 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/24/2015 |
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 | 10/01/2017 |
Device Catalogue Number | 050-87212 |
Device Lot Number | 14NR08037 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/24/2015 |
Initial Date FDA Received | 05/18/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/01/2014 |
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 | LIBERTY DIALYSIS CYCLER; PD SOLUTIONS |
|
|