MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-07 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[20162095]
Patient developed systemic hives, itching and swelling the evening after her first prosorba treatment (permcath placed twelve days earlier). Additional info rec'd 11/13/06 stated that pt also developed redness and purulent discharge from her right internal jugular permcath, nausea, vomiting fever, chills and pruritic chest pain 3 days after her treatment. The permcath was removed and cultured positive for staphylococcus aureus. The pt was hospitalized and diagnosed with thrombus in the right internal jugular vein and bacterial endocarditis. An echocardiogram revealed a small vegetation on the pt's tricuspid valve as well as a thrombus versus possible vegetation in the inferior vena cava. During this hospitalization she was also diagnosed with beta-thalassemia trait and microcytic anemia. She was anticoagulated and antibiotics were administered. She was discharged after 5 days.
Patient Sequence No: 1, Text Type: D, B5
[20447037]
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 would suggest a contributory relationship because the pt would not have had this central line if she had not been undergoing prosorba treatment. The prosorba column package insert contains a warning regarding the use of central venous catheters due to the high risk of infection and /or clotting in this population. It is of concern that this pt had the catheter placed 12 days prior to her first treatment and we have received no info regarding dressing changes/flushing of that catheter during that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3032792-2006-00018 |
| MDR Report Key | 794780 |
| Report Source | 05 |
| Date Received | 2006-12-07 |
| Date of Report | 2006-12-07 |
| Date of Event | 2006-10-15 |
| Report Date | 2006-12-06 |
| Date Reported to Mfgr | 2006-11-13 |
| Date Mfgr Received | 2006-11-13 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-12-18 |
| 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 NE 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 | PROSORBA COLUMN |
| Product Code | LQQ |
| Date Received | 2006-12-07 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RDN001E |
| ID Number | NA |
| Device Expiration Date | 2006-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 782400 |
| 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 | 2006-12-07 |