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

Catalog Number 03-2722-9

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Respiratory Acidosis (2482); Hypervolemia (2664)

Event Date 01/07/2014

Event Type  Death  

Event Description

A nurse reported that a pt admitted to the intensive care unit on (b)(6) 2013 had a cardiac/respiratory arrest during hemodialysis treatment on (b)(6) 2014.Treatment had been delayed on this same day due to the pt's hypotension (systolic blood pressure 60's) and hypoxia (o2 saturations low 80's%).The pt had acute respiratory distress syndrome and was on maximum ventilatory support (imv 30, fio2 100%, pc 30, peep 20), levophed drip at 30mcg/min, was severe fluid overloaded and was hypoxic prior to beginning hemodialysis.During treatment, the pt became hypotensive, bradycardic and quickly went asystolic.Maximum vasopressors were administered and the acls protocol was initiated.

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 completion of the physician's assessment of the reported info and the plant's investigation.The following mdrs are related: 2937457-2014-00229, 1713747-2014-00063, 8030665-2014-00166, 1225714-2014-00449 and 1225714-2014-00450.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3685198
• MDR Text Key: 4296478
• Report Number: 8030665-2014-00166
• 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
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• 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
• 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: 2008K2 HEMODIALYSIS MACHINE; OPTIFLUX DIALYZER; NATURALYTE; GRANUFLO
• Patient Outcome(s): Death
• Patient Age: 44 YR
• Patient Weight: 130