MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-15 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[15186923]
The evening after pt's third treatment she developed nausea and vomiting. She was admitted to the hospital and found to be hypotensive. Labs revealed decreased calcium, magnesium and potassium. She had tolerated her procedures well but had significant flaring post procedure. Due to hypotension, she was admitted to icu and administered pressors. Ct revealed a small amount of peritoneal fluid in abdomen. No definitive diagnosis was reached, physicians thought there might be an "intrinsic renal problem" and that patient may have a lupus-like syndrome with flaring of her rheumatoid arthritis. She was discharged to home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00018 |
| MDR Report Key | 646580 |
| Report Source | 05 |
| Date Received | 2005-11-15 |
| Date of Report | 2005-11-15 |
| Date of Event | 2005-10-09 |
| Report Date | 2005-11-10 |
| Date Mfgr Received | 2005-10-19 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2005-11-18 |
| 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 | JOSHUA LASKER |
| Manufacturer Street | 14715 BE 95TH ST, STE #100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422154 |
| Manufacturer G1 | FRESENIUS HEMOCARE |
| Manufacturer Street | 14715 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 | 2005-11-15 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RDN001A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 636087 |
| 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 | 2005-11-15 |