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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 103 11 13 001
Date submitted: 11/21/2013
Manufacturer:Baxter Healthcare.
Device Type:Cycler machine, HomeChoice 10.4
Description:Automated Peritoneal Dialysis, HomeChoice Pro APD system.
Medical Device Identifier:Product Code 5C8310, Product Name HomeChoice Pro APD system 115V
Product Code 5C4474, Product Name HomeChoice APD system
Product Code R5C8320, Product Name HomeChoice PRO APD System, 230V

.....................................

Swissmedic update codes :

Product Code : Product Name

5C4471 : HomeChoice APD System, 115V

5C4471R : HomeChoice APD System, 115V, Serviced

5C8310R : HomeChoice PRO APD System, 115V, Serviced

T5C4441 : HomeChoice (Yume) APD System, 230V

T5C8300 : HomeChoice PRO (Yume Plus) APD System, 230V

Reason of Field Safety Corrective Action:Baxter AG would like to inform you of important product information that is being sent to customers to describe HomeChoice 10.4 software Initial Drain logic as it relates to the comorbid condition of Ascites. Patients with ascites may have a large volum of fluid in their potential cavity. Patients with ascites who drain relatively large volumes (e.g. > 5 liter) when undergoing a paracentesis procedure should receive an albumin infusion to mitigate against developing hypotension and potential compromise of their hemodynamic status.
Remedy Action:Clinicians using the HomeChoice to treat patients diagnosed with End Stage Renal Disease coincident with Ascites should: - Be aware that HomeChoice will attempt to drain the patient to empty at the beginning of therapy (Initial drain) - Review HomeChoic IFU for additional details on homechoice 10.4 initial drain logic. - Consider alternative renal replacement therapy for patients with end stage renal disease and Ascites of significant volumes.
Athorized Representative/Importer/Distributor:Baxter AG
Report Source:NCMDR
Source Ref. Number:971386E8E9301
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20131112_09 ( Baxter Healthcare ).pdf