MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1998-12-23 for AN-69 FIL-20 manufactured by Gambro Healthcare.
[163785]
External blood leak at the port of the filter where the blood tubing connects. No pt injury or invervention.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8010182-1998-00004 |
MDR Report Key | 203675 |
Report Source | 06,07 |
Date Received | 1998-12-23 |
Date of Report | 1998-12-23 |
Date Mfgr Received | 1998-11-27 |
Date Added to Maude | 1998-12-29 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Remedial Action | RL |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AN-69 |
Generic Name | FILTRAL 20 |
Product Code | FJG |
Date Received | 1998-12-23 |
Model Number | NA |
Catalog Number | FIL-20 |
Lot Number | 98D0120B |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 197828 |
Manufacturer | GAMBRO HEALTHCARE |
Manufacturer Address | 1185 OAK ST LAKEWOOD CO 80215 US |
Baseline Brand Name | AN69 HOLLOW FIBER DIALYZER |
Baseline Generic Name | CAVH/D HEMOFILTRATION |
Baseline Model No | NA |
Baseline Catalog No | FIL-20 |
Baseline ID | NA |
Baseline Device Family | HEMOFILTRATION |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 36 |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K901368 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1998-12-23 |