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

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 09/02/2015

Event Type  Death  

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation and the plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A correspondence letter was received from the pt's daughter which indicated the pt was deceased.A follow up call was made with the clinic associated with pt's home treatment in order to gather additional details about the event surrounding the pt's death.Per the pt's registered nurse (rn) , the pt went to the hospital (reason unk), then went to rehab.Following rehab the pt returned to the hospital where she had a heart attack and passed away.According to the rn, the pt did not dialyze with the clinic during the time period between her initial hospitalization and her death.An internet search was conducted to locate pt's date of birth and it was determined that she was (b)(6) at the time of her passing.No further info could be obtained in regards to the sequence of events leading up to the pt's death.No reported allegations were made against the machine.Medical records have been requested.

Manufacturer Narrative

The device was not returned to the mfr for physical evaluation, and the machine serial number was not able to be obtained to date.Multiple attempts were made to obtain add'l info, however, they were unsuccessful.An investigation of the device mfg records was not able to be conducted by the mfr as the serial number of the 2008k@home hemodialysis machine in question was not provided.However, all device history records (dhr) are reviewed and released according to the "dhr review checklist and release procedure".P/n 500658; a device is not released if it does not meet requirements or is nonconforming.No medical records were made available, therefore, there is no way to confirm a causal relationship between the 2008k@home hemodialysis machine and the patient's death.

• 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 avenue
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5357021
• MDR Text Key: 35613050
• Report Number: 2937457-2016-00010
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

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
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 86 YR