Brand Name | CRIT-LINE BLOOD CHAMBER |
Manufacturer (Section D) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
|
kaysville UT |
|
Manufacturer (Section G) |
HEMA METRICS DIV. |
695 n 900 w |
|
kaysville UT 84037 |
|
Manufacturer Contact |
tanya
taft, rn, cnor
|
920 winter st. |
waltham, MA 02451-1457
|
7816999751
|
|
MDR Report Key | 4711638 |
MDR Text Key | 20776498 |
Report Number | 2937457-2015-00524 |
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,Company Representative,company representati |
Reporter Occupation |
Nurse
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
03/24/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/20/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | CL 10021021 |
Device Lot Number | 14111315 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/24/2015 |
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 | Z-1716-2015 |
Patient Sequence Number | 1 |
|
|