MAUDE MDR 1916793

MDR report key: 1916793
Report number: MW5018368
Event key: 0
Event type: 3
Date of event: 2010-09-10
Date received: 2010-11-24
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 500
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	GAMBRO PHOENIX DIALYSIS MACHINE	PHOENIX DIALYSIS MACHINE	GAMBRO AMERICAS HEADQUARTERS	FII			GE35807917					Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2010-11-24	0

Event Narratives#

D

Patient 1

D1 FLOWMETER FAILURE.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K030470	FII	NXSTAGE SYSTEM ONE	Nxstage Medical, Inc.	2003-07-07
510(k)	K881270	FII	GAMBRO MULTIPURPOSE SYSTEM MPS-10	Gambro, Inc.	1988-08-24
510(k)	K872364	FII	HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309	Travenol Laboratories, S.A.	1987-10-13
510(k)	K862716	FII	HEMOFILTRATION SYSTEM 10	Gambro, Inc.	1986-09-09
510(k)	K822386	FII	COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA	Hospal Medical Corp.	1982-10-06