MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-21 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[527693]
Patient hospitalized after 4 treatments with high fever and lower abdominal pain. Diagnosed with pancreatitis and a central venous catheter (cvc) infection. Treated with antibiotics and cvc discontinued. Patient's symptoms resolved and he was discharged after 3 days.
Patient Sequence No: 1, Text Type: D, B5
[7800038]
This investigation is a clinical investigation only. Return of product not requested as evaluation of device after use not relevant to reported event. The device was used according to labeled indications and in the appropriate environment. Temporal relationship of the event and prosorba might suggest a contributory relationship because the patient would not have had this central line he had not been undergoing prosorba treatment. It is not clear whether the episode of pancreatitis was in any way related to prosorba treatments.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3032792-2006-00010 |
| MDR Report Key | 764427 |
| Date Received | 2006-09-21 |
| Date of Report | 2006-09-21 |
| Date of Event | 2006-08-22 |
| Report Date | 2006-09-21 |
| Date Mfgr Received | 2006-08-22 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-09-27 |
| 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 NE 95TH ST. STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422154 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2006-09-21 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RGN001C |
| ID Number | NA |
| Device Expiration Date | 2007-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 752283 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-09-21 |