Alerta De Seguridad para Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate

Safety alert

2012-06-28

2012-06-28

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120628a.html

Medical device safety alert: fresenius naturalyte liquid acid concentrate and naturalyte granuflo (powder) acid concentrate the united states food and drug administrations (fda) has issued a class i recall concerning naturalyte liquid acid concentrate and naturalyte granuflo (powder) acid concentrate distributed by fresenius medical care north america. please refer to the fda website for the affected serial numbers. the manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in the products as mentioned above. inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. this may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. this product may cause serious adverse health consequences, including death. the fda recommended that health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient's overall bicarbonate levels. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm305630.Htm and http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm309990.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 june 2012.