MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS 2008K@HOME

Model Number K@HOME

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Septic Shock (2068)

Event Date 05/05/2011

Event Type  Death  

Event Description

The user facility reported that the patient had passed away when using the 2008k at home machine on (b)(6) 2011.There was no reported allegation against the device.

Manufacturer Narrative

A clinical investigation and medical assessment were performed.During the investigation, the facility reported that the patient died during treatment from septic shock due to his gall bladder bursting because of a severe infection.The facility reported that their biomed technician tested the machine and found no malfunctions with the device.Per the fms associate medical director, there is no current information to suggest that the patient's death was product related and there is no report of product malfunction.The investigation was limited by the fact that the patient's medical records and treatment information were not available for review.The actual device was not returned to the manufacturer.A fms hemodialysis technician serviced the machine at the user facility site.A visual inspection identified that the machine was functioning correctly.There was no additional evaluation available.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between march 21, 2011 to march 11, 2013.

• Brand Name: FRESENIUS 2008K@HOME
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4042021
• MDR Text Key: 4728365
• Report Number: 2937457-2014-02105
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K@HOME
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2011
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death