FRESENIUS 2008K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for FRESENIUS 2008K manufactured by Fresenius Medical Care North America.

Event Text Entries

[47341194] At 14:20 pm, almost 3 hours into dialysis treatment, the patient became unresponsive with no pulse. Cpr was initiated and 911 called. Ems arrived and cpr continued for 30 minutes when a pulse was finally achieved. Patient was subsequently transported to the hospital; however, expired in the emergency room. Dialysis machine was pulled for function testing after the event. Ph was noted to be out of range at 8. 4 using a phoenix meter. Pre-treatment ph was noted to be 7. 5. Calibration of phoenix meter was verified and subsequent tests gave same result of 8. 4.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5723155
• MDR Report Key: 5723155
• Date Received: 2016-05-25
• Date of Report: 2016-05-16
• Date of Event: 2016-05-02
• Date Facility Aware: 2016-05-02
• Report Date: 2016-05-16
• Date Reported to FDA: 2016-05-16
• Date Reported to Mfgr: 2016-05-16
• Date Added to Maude: 2016-06-14
• 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: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FRESENIUS
• Generic Name: HEMODIALYSIS MACHINE
• Product Code: ONW
• Date Received: 2016-05-25
• Model Number: 2008K
• Device Availability: Y
• Device Age: 9 YR
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FRESENIUS MEDICAL CARE NORTH AMERICA
• Manufacturer Address: 920 WINTER ST. WALTHAM MA 02451 US 02451

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2016-05-25