MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008

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

Patient Problem Death (1802)

Event Date 12/03/2014

Event Type  Death  

Event Description

It was reported by the patient's spouse that patient suffered cardiac arrest while on peritoneal dialysis treatment.Upon follow up with the patient's rn, the manufacturer learned the patient was on hemodialysis treatment at dialysis clinic on (b)(6) 2014.She had arrived at the hemodialysis center via stretcher.The patient denied any complaints.Upon initial assessment by the rn, there were no new findings or problems with the patient.The patient's hemodialysis treatment began at 3:15 pm without incident.The patient remained alert, with stable vital signs and denied complaints until 6:36 pm when she was found unresponsive and pulseless.The patient was given a 400 cc bolus of normal saline.Chest compression was started and ems was called.The dialysis clinic brought in an aed and the patient received one shock without success.She was taken into the er and was in icu.The rn reported the patient had another heart attack at 5:00 am and expired on (b)(6)2014.

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.Medical record review: medical records were received and reviewed by fresenius products caused or contributed to her events of cardiopulmonary arrest and subsequent death.The patient had multiple severe comorbidities including recent prolonged hospitalizations, infections and major surgeries.All functional testing of the dialysis machine performed by the dialysis clinic passed inspection on (b)(4) 2014 post event.There was no information in the medical record regarding the event of patient's death.There was no autopsy report or death certificate received.

Manufacturer Narrative

The actual device involved is not available for evaluation and the specific lot number is not known.Accordingly, a search of shipping records was performed to identify any product lots shipped to the customer three (3) months prior to the event.Lot history reviews were conducted for the identified lots; no manufacturing non-conformances were identified and the lots met all finished goods release criteria.The system level review of the 2008t device and concomitant products found no indication that the products caused or contributed to the clinical event.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 7816999000
• MDR Report Key: 4395660
• MDR Text Key: 5303351
• Report Number: 8030665-2015-00007
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility,consumer,health p
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2015; 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NATURALYTE BICARBONATE AND DRY ACID; FRESENIUS DIALIZER; GRANUFLO
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 61