Brand Name | FRESENIUS COMBISET 2008 |
Manufacturer (Section D) |
FRESENIUS MEDICAL CARE NORTH AMERICA |
reynosa |
MX |
|
Manufacturer (Section G) |
ERIKA DE REYNOSA, S.A. DE C.V. |
parque industrial reynosa |
|
reynosa, tamaulipas, cp 8878 0 |
MX
88780
|
|
Manufacturer Contact |
tanya
taft, rn, cnor
|
920 winter st |
waltham, MA 02451-1457
|
7816999000
|
|
MDR Report Key | 4553133 |
MDR Text Key | 5457537 |
Report Number | 8030665-2015-00103 |
Device Sequence Number | 1 |
Product Code |
FJK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K962081 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/28/2015 |
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 |
Health Professional
|
Device Model Number | COMBI SET |
Device Catalogue Number | 03-2622-3 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/28/2015 |
Initial Date FDA Received | 02/26/2015 |
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 |
Unknown
|
Patient Sequence Number | 1 |
Treatment | NATURALYTE,; FRESENIUS 2008T HEMODIALYSIS SYSTEM,; OPTIFLUX DIALYZER,; NATURALYTE LIQUID BICARBONATE |
Patient Outcome(s) |
Death;
|
|
|