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

Model Number K@HOME

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

Patient Problem Death (1802)

Event Date 10/09/2014

Event Type  Death  

Event Description

It was reported by a user facility that a home patient passed away on (b)(6).The patient was not on treatment at the time of her death and the time of last treatment is not yet available.Machine has been moved to the hosp.Further data will be updated in file when they are obtained from the facility.The facility does not allege any involvement of fresenius product or the treatment for the incident.Fmcc tech will be providing assistance to the facility in collecting machine data.It was determined that patient passed away within four hours of treatment.

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market clinical dept is in the process of obtaining patient medical records and a plant investigation is underway.A supplemental report will be submitted upon completion of the clinical staff's assessment of the reported info and the plant's investigation.

• Brand Name: FRESENIUS K@HOME
• Type of Device: ONW
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4253376
• MDR Text Key: 5016537
• Report Number: 2937457-2014-03129
• 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,Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2014

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
• Device Model Number: K@HOME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SALINE,; ACID CONCENTRATE,; LIQUID BICARBONATE NATURALYTE.
• Patient Outcome(s): Death