AKSYS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-03 for AKSYS * manufactured by Aksys Ltd..

Event Text Entries

[295565] Aksys hemodialysis machine had "dialysate leak". Pt had shortened treatment and pt missed treatment the next day while machine was being repaired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030467
• MDR Report Key: 501892
• Date Received: 2003-12-03
• Date of Report: 2003-11-20
• Date of Event: 2003-10-29
• Date Added to Maude: 2003-12-22
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AKSYS
• Generic Name: PERSONAL HEMODIALYSIS MACHINE
• Product Code: KPF
• Date Received: 2003-12-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 490679
• Manufacturer: AKSYS LTD.
• Manufacturer Address: TWO MARRIOTT DRIVE LINCOLNSHIRE IL 60069 US

Patients

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