MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Insufficient Information (3190)

Patient Problem Edema (1820)

Event Date 07/14/2014

Event Type  Death  

Event Description

It was reported by the user facility that the patient coded during hemodialysis.Medical records indicate the patient collapsed during dialysis and cpr was performed.Ems found in asystole/agonal, epi x's2 given, intubated and cpr was performed.Patient was transported to the hospital by ems unit.Upon arrival, patient bagged and w/a agonal rhythm-cpr continued and sodium bicarb given without success.The patient was pronounced at 1313, no pulses, no respirations, pupils fixed and dilated, asystole on monitor.

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.A supplemental report will be submitted upon final review of medical records by post market clinical physician and completion of the plant's investigation.This report is one of six related adverse event reports.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: corie vazquez ; 920 winter st.; waltham, MA 02451-1457 ; 7816999071
• MDR Report Key: 4066685
• MDR Text Key: 4734277
• Report Number: 8030665-2014-00620
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FRESENIUS 2008T HEMODIALYSIS SYSTEM; OPTIFLUX DIALYZER; GRANUFLO; 0.9% SODIUM CHLORIDE INJECTION; NATURALYTE
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 77