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

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 02/18/2010

Event Type  Death  

Event Description

The following is based on the medical records provided by the patient's attorney.It was indicated the decent expired on (b)(6) 2010.The decedent experienced a cardiovascular event.There are no treatment sheets for the event date.On (b)(6) 2010 the emergency nursing note reported; patient arrived via ems.Patient in cardiac pulmonary distress.Acls protocol initiated per ems.Cpr discontinued patient was pronounced dead.

Manufacturer Narrative

This is one event (death) reported for the same patient involving six separate products.A system level investigation is being performed to include all concomitant fmc products being used at the same time of the event.Medical records were rec'd for a total of 1350 pages and reviewed by the post market clinical specialist.The plaintiff's attorney alleged that the decedent experienced a cardiovascular event and subsequently expired on (b)(6) 2010 after the use of the product.No treatment records were rec'd for the day of the event or clinic facility log.No autopsy was performed; however, a death certificate was rec'd: immediate cause of death cardiopulmonary arrest, due to consequence of myocardial infarction, cad and esrd.There were no serum bicarbonate levels reported in the medical record.This is a patient with esrd that experienced a cardiovascular event and subsequently expired on (b)(6) 2010.Based on the info rec'd at this time, it is indeterminate if the product caused or contributed to this event.The device was not returned to the manufacturer.There is no history of specific malfunction or product being out of specifications, and the medical records rec'd for evaluation are incomplete.A supplemental report will be submitted upon completion of the investigation.Related mdr's: 2937457-2014-00515, 8030665-2014-00269, 1713747-2014-00158, 1713747-2014-99936, 1225714-2014-00269 and 1225714-2014-00270.

• Brand Name: MAFRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque ind. reynosa sur, brecha e99; apartado postal # 326; cd, reynosa, tampas 8878 0; MX 88780
• Manufacturer Contact: corie vasquez ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 3732829
• MDR Text Key: 4322830
• Report Number: 8030665-2014-00269
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• 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: 02/11/2014
• 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: NATURALYTE; FMC 2008K; MACHINE; GRANUFLO; DIALYZER; SALINE
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Weight: 102