Brand Name | CRIT-LINE BLOOD CHAMBER |
Manufacturer (Section D) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
concord CA |
|
Manufacturer (Section G) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
4040 nelson avenue |
|
concord CA 94520 |
|
Manufacturer Contact |
tanya
taft, rn, cnor
|
920 winter street |
waltham, MA 02451
|
8006621237
|
|
MDR Report Key | 4838016 |
MDR Text Key | 16629576 |
Report Number | 2937457-2015-01147 |
Device Sequence Number | 1 |
Product Code |
KOC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K935958 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
05/13/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/10/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | CL10021021 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/13/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | FA-2015-6 |
Patient Sequence Number | 1 |
|
|