FDA Adverse Event
Death
Summary report: N
PROSORBA COLUMN
MDR report key: 566284
·
Received January 14, 2005
Report
- Report Number
- 3032792-2005-00001
- Event Type
- Death
- Date Received
- January 14, 2005
- Date of Event
- December 13, 2004
- Report Date
- January 13, 2005
- Manufacturer
- FRESENIUS HEMOCARE, INC.
- Product Code
- LQQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT ADMITTED TO ICU IN THE EVENING AFTER THEIR 1ST PROSORBA TREATMENT "VENTILATED AND POSTURING". THEY WERE DIAGNOSED WITH BASAL GANGLIA STROKE POSSIBLY DUE TO HYPERTENSIVE CRISIS. RESULTS OF CT WERE NEGATIVE HOWEVER INFO IS PENDING ON A 2ND CT. ACCORDING TO THE APHERESIS PROVIDER, THE PT'S BP WAS VERY HIGH ON ADMISSION. THIS PT HAD NOT TAKEN THEIR ANTIHYPERTENSIVE MEDICATIONS PRIOR TO THEIR TREATMENT AND A FAMILY MEMBER REVEALED THAT THEY DID NOT TAKE THEM AFTER THEY RETURNED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSORBA COLUMN | PROSORBA COLUMN | LQQ | FRESENIUS HEMOCARE, INC. | 9798701 | QHN001A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | EFFOXOR, NORCO.| OXYCODONE, METOPROLO, ASPIRIN, GABAPENTIN,| PREDNISONE, PROPANOLOL, TRAZEDONE, CIMETIDINE, |