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

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

Patient Problems Death (1802); Myocardial Infarction (1969); Renal Failure (2041); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 01/25/2012

Event Type  Death  

Event Description

During review of med records, it was discovered pt had cardiac arrest and subsequently expired.Findings from the med records: pt in recliner at dialysis ctr.Staff states he completed one hour thirty minute of dialysis.Pt became less responsive than normal.Blood pressure low.Pt alert to voice and pain.Moved to micu, iv not attempted due to poor venous access and port still in left arm.Pt monitored in route.Transferred to er staff.Clinical impression respiratory failure at 1435, pt without a pulse, no respirations, pronounced dead.The death certificate reported: immediate cause of death: coronary artery disease, end stage renal disease, and chronic obstructive pulmonary disease and significant conditions contribute to death.Myocardial infarction.

Manufacturer Narrative

This report is being submitted as part of a sys level review.Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market clinical department physician is in the process of reviewing pt med records and a plant investigation is underway.A supplemental report will be submitted upon completion of the physician's assessment of the reported info and the plant's investigation.Related mdrs: 2937457-2014-01134, 8030665-2014-00495, 1713747-2014-00298, 1225714-2014-00413 and 1225714-2014-00414.

• Brand Name: FRESENIUS COMBISET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; parque industrial reynosa; reynosa, tamaulipas cp 8878 0
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3946618
• MDR Text Key: 4600958
• Report Number: 8030665-2014-00495
• 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: Attorney
• Type of Report: Initial
• Report Date: 05/20/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/19/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: SALINE,; NATURALYTE,; FRESENIUS 2008K HEMODIALYSIS MACHINE,; GRANUFLO; OPTIFLUX DIALYZER,
• Patient Outcome(s): Death
• Patient Age: 81 YR