FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-03-12 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K * manufactured by Fresenius Medical Care North America.

MAUDE Entry Details

• Report Number: 2937457-2003-00008
• MDR Report Key: 448561
• Report Source: 05
• Date Received: 2003-03-12
• Date of Event: 2003-02-12
• Date Mfgr Received: 2003-02-12
• Device Manufacturer Date: 2002-01-01
• Date Added to Maude: 2003-03-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: ELVY DIZON, BSN, RN, CNN
• Manufacturer Street: 2637 SHADELANDS DR
• Manufacturer City: WALNUT CREEK CA 94598
• Manufacturer Country: US
• Manufacturer Postal: 94598
• Manufacturer Phone: 9252950200
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FRESENIUS DIALYSIS DELIVERY SYSTEM
• Generic Name: *
• Product Code: FIL
• Date Received: 2003-03-12
• Model Number: 2008K
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: 1 YR
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 437544
• Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
• Manufacturer Address: 2637 SHADELANDS DR. WALNUT CREEK CA 94598 US
• Baseline Brand Name: FRESENIUS DIALYSIS DELIVERY SYSTEM
• Baseline Generic Name: HEMODIALYSIS MACHINE
• Baseline Model No: 2008K
• Baseline Catalog No: F002-40
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K994267
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-03-12