MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBI SET; NONE

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

Patient Problem Death (1802)

Event Date 10/01/2013

Event Type  Death  

Event Description

A hemodialysis technician reported that in (b)(6) 2013 a pt expired while connected to the machine.After following up with the technician, he stated that the pt's death was in no way related to the machine.He stated that the machine passed a series of adverse event testing during their investigation and was returned to the floor for use.The specific date of the pt's death was not provided.The cause of the pt's death was not provided.

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, no definitive conclusion can be drawn.The post market clinical staff is currently in the process of requesting pt medical records including a death certificate and autopsy report.A supplemental report will be filed upon completion of investigation.Related mds: 1713747-2014-00019, 1713747-2014-00020, 8030665-2014-00048, 1225714-2014-00085 and 1225714-2014-00086.

• Brand Name: COMBI SET
• Type of Device: NONE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3590968
• MDR Text Key: 4168823
• Report Number: 8030665-2014-00048
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K96208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NATURLTYE; GRANUFLO; 2008K; UNK FRESENIUS TUBING; UNK FRESENIUS DIALYZER; UNK FRESENIUS SALINE
• Patient Outcome(s): Death