MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-06-30 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[419130]
Pt diagnosed with popliteal artery thrombosis the day after their first treatment for rheumatoid arthritis. It was also found one that day that their dialysis shunt had occluded. The day prior to their prosorba treatment, it is stated that their dialysis left them in a more negative fluid balance than usual which led to their having a low blood pressure on the day of prosorba. This pt also is stated to have "severe arterial obstructive disease from their diabetes and was not taking aspirin due to hematochezia secondary to hemorrhoids. Lastly, they were taking up to 50 mg of cortisone/day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00011 |
| MDR Report Key | 619414 |
| Report Source | 05 |
| Date Received | 2005-06-30 |
| Date of Report | 2005-06-30 |
| Date of Event | 2005-05-31 |
| Date Mfgr Received | 2005-05-31 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-07-07 |
| 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 | 3 |
| Manufacturer Contact | JOE WINSLOW |
| Manufacturer Street | 14715 NE 95TH ST, STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 8006621237 |
| Manufacturer G1 | FRESENIUS HEMOCARE |
| Manufacturer Street | 14787 NE 95TH ST, 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 | IMMUNOADSORPTION COLUMN |
| Product Code | LQQ |
| Date Received | 2005-06-30 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RAN001 |
| ID Number | NA |
| Device Expiration Date | 2005-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 609102 |
| 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. Hospitalization | 2005-06-30 |