Medical device manufacturer, Baxter Healthcare, has issued a field safety notice concerning HomeChoice Automated Peritoneal Dialysis system, 230V (product code: 5C4474; software version: v10.4).
Baxter is sending a communication to describe HomeChoice 10.4 software Initial Drin logic in patients with unrelated co-morbid condition of Ascites.
Ascites is the abnormal accumulation of fluid in the peritoneal cavity. Peritoneal dialysis patients with Ascites may have large volumes of fluid in their peritoneal cavity. When these patients drain significant amounts of ascetic fluid (e.g. more than 5 liters), studies suggest that medical intervention may be required to mitigate against developing hypotension and potential hemodynamic compromise.
HomeChoice software is designed to empty the peritoneal cavity during Initial Drain. Previous versions of HomeChoice software permitted the operator to stop the active Initial Drain and bypass it. The current version of the HomeChoice software version 10.4 removed the option to bypass an active Initial Drain in order to mitigate against Unintended Increased Intraperitoneal Volume.
Patients diagnosed with the co-morid condition of Ascites who drain to empty may be at an increase risk of hypotension and compromise of their hemodynamic status.
Therefore, Baxter advises that clinicians using the HomeChoice to treat patients diagnosed with End Stage Renal Disease coincident with Ascites should:
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 October 2013