Baxter (NYSE:BAX) alerted Canadian peritoneal dialysis patients about potential overfill issues with its HomeChoice machines and tipped Hong Kong regulators about the risks of altering the HomeChoice device’s power cord to fit local outlets.
Deerfield, Ill.-based Baxter and Health Canada said software updates designed to prevent overfill of the peritoneal cavity during dialysis may not stop its occurrence, sometimes caused by "mistakes when entering information for the set-up of your dialysis machine," according to a public notice posted north of the border.
"If you have overfill, you could feel pain, overstretching in your belly, feel sick to your stomach, find it hard to breathe or have problems at the place solution leaves your abdomen," according to the notice. "You should look for signs of overfill and talk to your doctor or clinic as soon as possible if you notice any of them."
In Hong Kong, the Dept. of Health said it received a safety alert from Baxter "regarding the integrity of the AC power cords of its HomeChoice Automated Peritoneal Dialysis Systems."
"The DH received a notification from Baxter that the company was aware of a modification carried out to the AC power cords used on the device which involved fitting of a local AC plug that could affect the integrity of the AC power cord in use," according to the HKHD. "According to Baxter, although all power cords for the device currently being used in Hong Kong fulfilled the local standards and have passed relevant electrical safety tests before use, the overall integrity of these power cords was uncertain and may lead to 2 potential risks to users. Firstly, the device may fail to function and the dialysis session will be delayed. Secondly, there is a potential for an electrical fire or shock. However, the possibility of the occurrence of these risks is very low."
Baxter told the health department that it will arrange to replace the power cords on the roughly 600 devices in use in Hong Kong. There have been no reports of adverse events related to the power cord issue, according to the notice.