MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1998-01-16 for AN-69 * FIL-20 manufactured by Gambro Healthcare.
[97938]
Pt reaction 5-7 mins into treatment. Pt taken off, dialyzer changed and treatment resumed. No further problem. Pt stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-1997-00002 |
| MDR Report Key | 179608 |
| Report Source | 06,07 |
| Date Received | 1998-01-16 |
| Date of Report | 1998-01-16 |
| Date of Event | 1997-12-08 |
| Date Mfgr Received | 1997-12-19 |
| Date Added to Maude | 1998-07-31 |
| 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 |
| 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 | 1998-01-16 |
| Model Number | * |
| Catalog Number | FIL-20 |
| Lot Number | 96K1258 |
| 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 | 174645 |
| 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 | 1998-01-16 |