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

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

Patient Problem Death (1802)

Event Date 12/15/2014

Event Type  Death  

Event Description

The pt's rn called in to report the pt had expired after treatment at home.Findings from the medical records: direct quotes from emergency report-date time seen (b)(6) 2014 13:55 via ems.Family wanted the pt to be brought to the hospital to confirm death.Pt in asystole at the time and no intervention being done.History of present illness-the pt presents in cardio-respiratory arrest, (b)(6) old, white female presents from home with cardiac arrest.Paramedics called earlier and asked to discontinue code, secondary to family request.There is a do not resuscitate at site.Daughter did have power of attorney paperwork.The pt has been in a coma at home for 7 years following a stroke.Pt is on dialysis and was well until the 9 months when her health started declining rapidly.Emergency room physician instructed the paramedics to hold on any cpr.No cpr was done during transport.There was no pulse, no spontaneous respirations on the monitor, she was pronounced at 13:56.Family was at bedside.

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 information provided, it is unk how the device may have caused or contributed to the event.Medical record review: medical records were provided and have been reviewed by post market surveillance clinical staff.It was noted that there is insufficient information in the current medical records to make a conclusion of relationship to fresenius product and the reported event.Further attempts will be made for additional information and supplemental report will be filed base on findings.A supplemental report will be submitted upon completion of the plant's investigation.

• Brand Name: FRESENIUS K AT HOME
• 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, rn ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4420509
• MDR Text Key: 16449227
• Report Number: 2937457-2015-00039
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/14/2015
• 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
• Treatment: OPTIFLUX 160NRE DIALYZER; NATURALYTE ACID; HOME HEMO COMBISET; NATURALYTE LIQUID BICARBONATE; SALINE
• Patient Outcome(s): Death
• Patient Age: 82 YR