MAUDE MDR 179608

MDR report key: 179608
Report number: 8010182-1997-00002
Event key: 0
Event type: 3
Date of event: 1997-12-08
Date received: 1998-01-16
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	AN-69	FILTRAL 20	GAMBRO HEALTHCARE	FJG	*	FIL-20	96K1258		K901368	N	R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1998-01-16	0	1. O

Event Narratives#

D

Patient 1

PT REACTION 5-7 MINS INTO TREATMENT. PT TAKEN OFF, DIALYZER CHANGED AND TREATMENT RESUMED. NO FURTHER PROBLEM. PT STABLE.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K933681	FJG	GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS	Cobe Renal Care, Inc.	1994-09-07
510(k)	K933680	FJG	GAMBRO LUNDIA PRO 200 DIALYZER	Cobe Renal Care, Inc.	1994-08-26
510(k)	K920693	FJG	DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9	National Medical Care, Medical Products Div., Inc.	1992-09-21
510(k)	K915504	FJG	GAMBRO LUNDIA ALPHA HEMODIALYZERS	C.G.H. Medical, Inc.	1992-03-06
510(k)	K901368	FJG	HEMOSPAL KITS A1, A2D, AO, & A1D	Gambro-Hospal, Inc.	1990-08-02