MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-12-01 for FILTRAL 20 FIL-20 manufactured by Hospal Industrie.
[21608452]
The pt became tachycardic, diaphoretic and panicky. Pt complained of shortness of breath and nausea two to three minutes into treatment. The pt was afebrile and there was no change in blood pressure. The treatment was terminated and clinic staff administered 25mg benadryl followed 1/2 hours later by another 25mg benadryl. A second dialyzer was primed with three liters normal saline and treatment reinitiated as the pt slept. Within two to three minutes of initiating the treatment, the pt awakened with the same symptoms. Clinic staff administered 25mg benadryl. This was the third of three reactions with this pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-1999-00027 |
| MDR Report Key | 251793 |
| Report Source | 05,06,07 |
| Date Received | 1999-12-01 |
| Date of Report | 1999-11-01 |
| Date of Event | 1999-11-01 |
| Date Mfgr Received | 1999-11-01 |
| Date Added to Maude | 1999-12-02 |
| 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, QA |
| Manufacturer Street | 1185 OAK ST |
| 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 | 1999-12-01 |
| Model Number | NA |
| Catalog Number | FIL-20 |
| Lot Number | 99C1265 |
| 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 | 243863 |
| Manufacturer | HOSPAL INDUSTRIE |
| Manufacturer Address | 7, AVENUE 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. Required No Informationntervention | 1999-12-01 |