* 2008K2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-19 for * 2008K2 manufactured by Fresenius Medical Care North America.

Event Text Entries

[3257655] Hemodialysis started at 0920. At 0925 the machine indicated dial valve failure 1 and machine went into bypass. Patient not rinsed back. Md in room. H&h drawn - new tubing and machine set up. Hd completed. Patient discharged. Discussed with company representative. Test run - could not duplicate alarm. What was the original intended procedure? Hemodyalisis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3021316
• MDR Report Key: 3021316
• Date Received: 2013-03-19
• Date of Report: 2013-03-19
• Date of Event: 2013-03-14
• Report Date: 2013-03-19
• Date Reported to FDA: 2013-03-19
• Date Reported to Mfgr: 2013-03-26
• Date Added to Maude: 2013-03-26
• 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: *
• Generic Name: SYSTEM, HEMODIALYSIS
• Product Code: MQS
• Date Received: 2013-03-19
• Model Number: 2008K2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
• Manufacturer Address: 920 WINTER STREET, SUITE A WALTHAM MA 02451 US 02451

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-03-19