|
Catalog Number 0102103 |
Event Date 11/11/1994 |
Patient Outcome
Required Intervention;
|
Event Description
|
Facility alleges dialyzer blood leak.
Ebl>100cc no pt injury reported.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | BAXTER CA210 (HF/CA/2.1/M) |
Type of Device | DIALYZER |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
BAXTER HEALTHCARE CORP. |
p.o. box 7780-5030 |
philadelphia PA 19182 |
|
Manufacturer (Section D) |
BAXTER HEALTHCARE CORP. |
p.o. box 7780-5030 |
philadelphia PA 19182 |
|
Device Event Key | 100055 |
MDR Report Key | 101633 |
Event Key | 95559 |
Report Number | 101633 |
Device Sequence Number | 1 |
Product Code | FJI |
Report Source |
Distributor
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
01/17/1996 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/24/1996 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0102103 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 11/11/1994 |
Event Location |
Outpatient Treatment Facility
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
No Answer Provided
|
|
|
Database last updated on February 28, 2009
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH