MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-03-08 for FILTRAL 20 FIL-20 manufactured by Hospal Industrie.
[22181286]
Approximately 90 seconds into the treatment, the pt complained of shortness of breath. The pt was noted to be diaphoretic and anxious, with a decrease in blood pressure and an increase in pulse. The pt was switched to a polyflux 17s dialyzer. The pt required oxygen and underwent testing; lab analysis was positive for allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8010182-2000-00002 |
MDR Report Key | 267760 |
Report Source | 05,06 |
Date Received | 2000-03-08 |
Date of Report | 2000-02-07 |
Date of Event | 2000-02-04 |
Date Mfgr Received | 2000-02-07 |
Date Added to Maude | 2000-03-09 |
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 |
Manufacturer Contact | ROBBIN PROCOPIO |
Manufacturer Street | 10810 W. COLLINS AVE |
Manufacturer City | LAKEWOOD CO 80215 |
Manufacturer Country | US |
Manufacturer Postal | 80215 |
Manufacturer Phone | 3032314186 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FILTRAL 20 |
Generic Name | DIALYZER |
Product Code | FJG |
Date Received | 2000-03-08 |
Model Number | NA |
Catalog Number | FIL-20 |
Lot Number | 98E1561 |
ID Number | NA |
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 | 259208 |
Manufacturer | HOSPAL INDUSTRIE |
Manufacturer Address | 7, AVE LIONEL TERRAY MEYZIEU FR 69330 |
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 | 2000-03-08 |