MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-29 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[369879]
Patient who developed cardiac arrhythmias two days after pt's second treatment and also a "right cerebral ischemic insult" (paresis left arm). Despite this pt underwent a third treatment 2 weeks later. Late that evening pt had another stroke-like episode. Pt expired 2 days later, no autopsy done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00008 |
| MDR Report Key | 598176 |
| Report Source | 05 |
| Date Received | 2005-04-29 |
| Date of Report | 2005-04-28 |
| Date of Event | 2005-03-24 |
| Date Facility Aware | 2005-03-24 |
| Date Mfgr Received | 2005-03-24 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-05-04 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KAREN QUARFORD |
| Manufacturer Street | 14787 NE 95TH STREET SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422154 |
| Manufacturer G1 | FRESENIUM HEMOCARE |
| Manufacturer Street | 14787 NE 95TH STREET STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSORBA COLUMN |
| Generic Name | PROSORBA COLUMN |
| Product Code | LQQ |
| Date Received | 2005-04-29 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | QKN002B |
| ID Number | * |
| Device Expiration Date | 2006-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 588014 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Baseline Brand Name | PROSORBA COLUMN |
| Baseline Generic Name | THERAPEUTIC PLASMA EXCHA |
| Baseline Catalog No | 9798701 |
| Baseline Device Family | PROTEIN A IMMUNOADSORPTION COL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-04-29 |