FRESENIUS OPTIFLUX 160-NRE 160 NRE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-27 for FRESENIUS OPTIFLUX 160-NRE 160 NRE * manufactured by Fresenius Medical Care North America.

Event Text Entries

[412039] Treatment started - at 0715 patient complaint of upset stomach, became anxious, and exhibited seizure-like activity (eyes with fixed stare, and slight twitebing ) placed in trendelenbury position, reinfused. Ems called. Blood sugar checked (60) and pulse audible at 62. Rescue breaths given. Blood pressure 100/66 0720 ems arrived & pt transported to hospital er.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	638116
MDR Report Key	638116
Date Received	2005-09-27
Date of Report	2005-08-26
Date of Event	2005-08-22
Date Facility Aware	2005-08-22
Report Date	2005-08-26
Date Reported to Mfgr	2005-08-26
Date Added to Maude	2005-09-29
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
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
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	FRESENIUS OPTIFLUX 160-NRE
Generic Name	DIALYZER
Product Code	FJY
Date Received	2005-09-27
Model Number	160 NRE
Catalog Number	*
Lot Number	0500316E
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	*
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	627663
Manufacturer	FRESENIUS MEDICAL CARE NORTH AMERICA
Manufacturer Address	95 HAYDEN AVE LEXINGTON MA 02420 US
Baseline Brand Name	OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Baseline Generic Name	DIALYZER
Baseline Model No	NA
Baseline Catalog No	0500316E
Baseline ID	0500316E

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2005-09-27