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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 080 03 14 000
Date submitted: 3/18/2014
Manufacturer:Baxter Healthcare
Device Type:HomeChoice Automated Peritoneal Dialysis Systems, HomeChoice PRO Automated Peritoneal Dialysis Systems
Description:Peritoneal Dialysis Units
Medical Device Identifier:Product Nos.: 5C4471, 5C4471R, 5C8310, 5C8320, 5C8310R
Reason of Field Safety Corrective Action:Baxter Healthcare is implementing additional warning label. Specific population using peritoneal dialysis therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. The additional warning identifies symptoms related to unintended Increased Intraperitoneal volume (IIPV) that may result in theses specific populations and provides specific instructions for the patient to follow if Increased Intraperitoneal Volume (IIPV) that is suspected.
Remedy Action:Please keep a copy of this warning letter and the attachment 1 with your Homechoice manual.
Athorized Representative/Importer/Distributor:Baxter AG, 011 4343700
Report Source:NCMDR
Source Ref. Number:BA2E4DC757253
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Baxter Healthcare-new.pdf