Brand Name | 2008T HEMODIALYSIS SYS., WITH CDX |
Manufacturer (Section D) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
concord CA |
|
Manufacturer (Section G) |
FRESENIUS MEDICAL CARE NORTH AMERICA, WALNUT CREEK PLANT |
4040 nelson ave. |
|
concord CA 94520 |
|
Manufacturer Contact |
tanya
taft, rn, cnor
|
920 winter st. |
waltham, MA 02451-1457
|
7816999000
|
|
MDR Report Key | 3640909 |
MDR Text Key | 16449895 |
Report Number | 2937457-2014-00147 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093902 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
01/13/2014 |
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 |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/06/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/01/2012 |
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 | MEDISYSTEM STREAMLINE BLOODLINES; FRESENIUS OPTIFLUX DIALYZER; SALINE; MEDISYSTEM FISTULA NEEDLE; ROCKWELL ACIDS; FRESENIUS BLOODLINES |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Weight | 68 |