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 Problem Death (1802)

Event Date 10/25/2013

Event Type  Death  

Manufacturer Narrative

No parts were not 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 caregiver which indicated the pt was deceased.No details, including the reporters name were provided.A follow up call was made with the clinic associated with pt's home treatment in order to gather additional details about the events surrounding the pt's death.It was reported the pt transferred their dialysis treatment elsewhere.This clinic reported two known locations the pt received treatment.Follow ups with those two locations were unable to provide additional info regarding the pt or the pt's death.An internet search was conducted to locate pt's date of birth and date of death.The pt's date of death was reported as (b)(6) 2013.No further info could be obtained in regards to the sequence of events leading up to and including the pt's death.No reported allegations were made against the machine.

Manufacturer Narrative

No devices were returned to the mfr for physical evaluation and field service was not requested; therefore, the failure mode cannot be confirmed.Serial number was not provided.All products are released to spec.

• 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; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5313334
• MDR Text Key: 34076402
• Report Number: 2937457-2015-01720
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K@HOME
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR