FILClass IILife-sustaining

System, Dialysate Delivery, Single Pass

Gastroenterology, Urology · 21 CFR 876.5820

MDR events58All time

Recalls0All time

Registered firms2Currently listed

510(k) clearances8All time

Recent MDR events

58 adverse event reports on file

AVAULTA BIOSYNTHETIC SUPPORT SYSTEMNov 12, 2009
InjurySofradim Production1018233-2009-00128
AVAULTA BIOSYNTHETIC SUPPORT SYSTEMJun 20, 2009
InjurySofradim Production1018233-2009-00062
FRESENIUS DIALYSIS DELIVERY SYSTEMFeb 1, 2007
InjuryFresenius Medical Care-north America2937457-2007-00003
FRESENIUS DIALYSIS DELIVERY SYSTEMFeb 1, 2007
MalfunctionFresenius Medical Care North America2937457-2007-00002
FRESENIUS DIALYSIS DELIVERY SYSTEMOct 19, 2006
InjuryFresenius Medical Care North America2937457-2006-00010
FRESENIUS DIALYSIS DELIVERY SYSTEMJun 29, 2006
InjuryFresenius Medical Care North America2937457-2006-00004
FRESENIUS DIALYSIS DELIVERY SYSTEMMar 31, 2006
MalfunctionFresenius Medical Care-north America2937457-2006-00003
FRESENIUS DIALYSIS DELIVERY SYSTEMNov 8, 2005
InjuryFresenius Medical Care North America2937457-2005-00019
*Oct 19, 2005
DeathFresenius Medical Care-north America2937457-2005-00015
2008K HEMODIALYSIS MACHINESep 17, 2005
DeathFresenius Medical Care;636939

Event type breakdown

Malfunction37

Injury13

Death8

Most-reported manufacturers

Fresenius Medical Care-north America34 Fresenius Medical Care North America19 Sofradim Production2 Fresenius Medical Care - North America1 Fresenius Medical Care;1 Fresenius Medical-care North America1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

2 firms currently registered for this product code

510(k) clearances

8 clearances for this product code