MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-30 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[414841]
An ra pt had her 5th prosorba five days before date of event and her central venous catheter was removed four days before date of event due to catheter infection. She was then admitted to the hospital on the day of event with chest pain and diagnosed with pulmonary embolism and dvt in her internal jugular vein (where central venous catheter was). She was also diagnosed with tricuspid valve endocarditis. Additionally she was noted as having hypotension during her prosorba treatments which was likely due to concurrent use of an ace inhibitor during her treatments. Ace inhibitors are contraindicated for use in patients undergoing prosorba treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00020 |
| MDR Report Key | 649133 |
| Report Source | 05 |
| Date Received | 2005-11-30 |
| Date of Report | 2005-11-30 |
| Date of Event | 2005-09-13 |
| Report Date | 2005-11-30 |
| Date Mfgr Received | 2005-11-08 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2005-12-06 |
| 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 | * |
| Manufacturer Street | * |
| Manufacturer City | * 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 | 2005-11-30 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RDN001A |
| ID Number | NA |
| Device Expiration Date | 2006-10-31 |
| 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 | 638626 |
| 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. Life Threatening | 2005-11-30 |