We have read on several news sites today, including the FDA site that Baxter are urgently recalling a number of peritoneal dialysis machines manufactured by them. A full list of models affected is given on the FDA site, and on Baxter's press release section of their web site.
Obviously it is important that users of these machines check immediately the status of their machine, so we are reproducing the machine details here.
Affected model numbers are:
Home Choice - 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D, 5C4474DR
Home Choice Pro - 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R
All systems with these model numbers are affected.
This is because of reports of serious injuries and at least one death associated with Increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV can cause serious breathing and heart problems that can result in serious injury or death.
Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended.
Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Public Contact: If you need assistance with your HomeChoice or HomeChoice PRO, call the Baxter Customer Service line, available 24 hours and day, 7 days a week at 1-800-553-6898.
We suggest you have a read of both the web pages linked to above, in case we have missed out anything vital in our summary of the press release.
