Brand Name | PRISMAFLEX HF1000 |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
BAXTER HEALTHCARE - MEYZIEU |
meyzieu cedex rhone |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - MEYZIEU |
7, av lionel terray, b.p. 126 |
|
meyzieu cedex rhone 69883 |
FR
69883
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 7654594 |
MDR Text Key | 112886882 |
Report Number | 8010182-2018-00066 |
Device Sequence Number | 1 |
Product Code |
KDI
|
UDI-Device Identifier | 07332414069254 |
UDI-Public | (01)07332414069254 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042938 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
07/02/2018,08/03/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/02/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/01/2020 |
Device Catalogue Number | 107140 |
Device Lot Number | 18B0102 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/02/2018 |
Distributor Facility Aware Date | 06/04/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/02/2018 |
Date Manufacturer Received | 07/10/2018 |
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 |
N
|
Patient Sequence Number | 1 |
Treatment | PRISMAFLEX MACHINE |
|
|