FDA posts recall notice of hemodialysis system distributed by Baxter

DEERFIELD, Illinois — The U.S. Food and Drug Administration posted notice of a Class I recall of a hemodialysis system distributed by Baxter International Inc., warning that in extreme cases the machine’s defect could result in serious injuries or death.

Baxter sent its customers the urgent recall on Jan. 11, after it received reports of “clinically significant fluid imbalances” caused by the Aquarius hemodialysis system. Hemodialysis systems are used to clean waste and excess fluid from patients’ bodies after their kidneys have failed, as well as monitor fluid going in and out of patients’ bodies.

The problem with the Aquarius system arises when health workers override an alarm that’s triggered when the system detects a fluid imbalance. By repeatedly overriding the alarm without solving the problem that triggered it — which may be a closed clamp or kinked line — it’s possible to remove or replace too much fluid from the patient’s body, the FDA said.

Baxter told Reuters that the problem affected fewer than 150 units and could be solved by a software update that it expects to implement by the end of the first quarter. The expenses associated with the software update are expected to be immaterial to the company, Baxter said.

Baxter last year acquired the hemodialysis product line that includes the Aquarius from Edwards Lifesciences Corp. Baxter said Edwards still holds regulatory responsibility for the product and that the two companies would work together to conduct the recall. Edwards said it is “unaware of” any injuries or deaths caused by the Aquarius’ problem, Reuters reported.

A Class I recall is ”the most serious type of recall and involves situations in which there is a reasonable probability” that the products in question “will cause serious adverse health consequences or death,” the FDA said.

Baxter’s stock price on Friday was largely unaffected by news of the recall, which was published by the FDA Thursday night. Recalls are fairly common for medical device and other types of health care companies.

Baxter reported an 1 percent increase in fourth-quarter profits Thursday, in line with analysts’ expectations. Sales jumped 11 percent to $3.5 billion.