Brand Name | PRISMAFLEX HF1400 |
Type of Device | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
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 | 10693092 |
MDR Text Key | 211757376 |
Report Number | 8010182-2020-00213 |
Device Sequence Number | 1 |
Product Code |
KDI
|
Combination Product (y/n) | Y |
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,Followup |
Report Date |
10/15/2020,11/25/2020 |
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
|
Device Catalogue Number | 107142 |
Device Lot Number | 20F0305 |
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 | 10/15/2020 |
Distributor Facility Aware Date | 09/22/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/15/2020 |
Initial Date Manufacturer Received |
09/22/2020 |
Initial Date FDA Received | 10/16/2020 |
Supplement Dates Manufacturer Received | 11/19/2020 11/19/2020
|
Supplement Dates FDA Received | 11/20/2020 11/25/2020
|
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 | PRISMAFLEX CONTROL UNIT; PRISMAFLO BLOOD WARMER |
Patient Outcome(s) |
Death;
|
Patient Age | 78 YR |
Patient Weight | 109 |