Dialysis Drug Recalled After Patient Death

Published on Controlled Environments Magazine (http://www.cemag.us)

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Dialysis Drug Recalled After Patient Death

A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death.

NaturaLyte Liquid Bicarbonate Concentrate is used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated for use with a three-stream

hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.

The product may develop higher than expected bacteria levels during its shelf life. Lab testing identified the bacteria as Halomonas (species 1, 2, 3), a gram negative bacteria typically found in water with high salt concentration.

The FDA has received one report of death and two reports of injury that may be related to use of this product. The use of affected product may cause serious adverse health consequences, including sepsis, bacteremia, and death.

The affected products were manufactured August 2013 to April 2014 and distributed August 15,

2013 to April 7, 2014.

Class I recalls are the most serious type of recall and involve situations in which there is a

reasonable probability that use of these products will cause serious adverse health

consequences or death.

Release Date: May 28, 2014

Source: FDA [1]

Source URL (retrieved on 06/01/2014 - 2:38am):  http://www.cemag.us/news/2014/05/dialysis-drug-recalled-afterpatient-

death?location=top

Links:

 [1] http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm399124.htm downloaded on 01-Jun-14 2:40 PM