|
Catalog Number 0117325 |
Event Date 01/11/1991 |
Patient Outcome
Required Intervention;
|
Event Description
|
Dr facility alleges the dialyzer leaked on reuse #5.
Ebl > 100 cc.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | BAXTER CA110 (HF/CA/1.1/L) |
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 | 112450 |
MDR Report Key | 114555 |
Event Key | 107737 |
Report Number | 114555 |
Device Sequence Number | 1 |
Product Code | FJI |
Report Source |
Distributor
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/08/1996 |
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 | 0117325 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 01/11/1991 |
Event Location |
Outpatient Treatment Facility
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
No Answer Provided
|
|
|
Database last updated on January 30, 2009
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