OPTIFLUX OPTIFLUX 200A NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-01 for OPTIFLUX OPTIFLUX 200A NA manufactured by Fredenius Medical Care.

Event Text Entries

[354625] Pt experienced chills during last hour of hemodialysis treatment. Therapy provided with 16th use of hemodialyzer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 517823
• MDR Report Key: 517823
• Date Received: 2004-03-01
• Date of Report: 2003-12-01
• Date of Event: 2003-11-07
• Date Facility Aware: 2003-11-18
• Report Date: 2003-12-01
• Date Reported to Mfgr: 2003-12-02
• Date Added to Maude: 2004-03-29
• 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 Sequence Number: 1

• Brand Name: OPTIFLUX
• Generic Name: HEMODIALYZER
• Product Code: KDI
• Date Received: 2004-03-01
• Model Number: OPTIFLUX 200A
• Catalog Number: NA
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 506851
• Manufacturer: FREDENIUS MEDICAL CARE
• Manufacturer Address: 96 HAYDEN AVE LEXINGTON MA 02420 US

Device Sequence Number: 2

• Brand Name: RENATRON
• Generic Name: REPROCESSING DEVICE
• Product Code: LIF
• Date Received: 2004-03-01
• Model Number: RS8330
• Catalog Number: NA
• Lot Number: *
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 506853
• Manufacturer: MINNTECH CORP
• Manufacturer Address: 14605 28TH AVE NORTH MINNEAPOLIS MN 55447 US
• Baseline Brand Name: *
• Baseline Generic Name: HEMODIALZER
• Baseline Model No: RS8330
• Baseline Catalog No: NA
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2004-03-01