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

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

Patient Problem Death (1802)

Event Date 05/08/2014

Event Type  Death  

Event Description

It was reported to fresenius medical care (b)(4) that a home hemodialysis patient passed away.The device was not in use at the time of his death.Follow up with the nurse confirmed that the patient passed away in the evening on (b)(6) 2014 and he had his last home hemodialysis treatment at night on (b)(6) 2014.The nurse will not confirm the cause of death.There is no allegation of malfunction against the device.

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market clinical department is in the process of requesting patient medical records and treatment data information regarding the reported expiration independent of treatment with the device.A supplemental medwatch report will be submitted upon completion of the investigation.Related mdrs 2937457-2014-00993 and 1225714-2014-04145.

• Brand Name: K@HOME HEMODIALYSIS MACHINE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3883452
• MDR Text Key: 4565721
• Report Number: 2937457-2014-00993
• 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: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2014

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: No
• 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