A dozen children who underwent cardiac procedures at Children’s Hospital New Orleans earlier this year have been infected with myobacterium previously linked to LivaNova’s (NSDQ:LIVN) 3T Heater-Cooler systems, according to a STAT News report.
A total of 55 children had heart surgery between May and July at the facilities, with 7 of the 12 patients with infections identified through phone calls to families.
A number of patients who have only received phone calls are slated to see doctors this week, leaving the possibility that the numbers will grow, STAT reports.
The hospital has since replaced the contaminated machine, according to the report.
An investigation began after 3 incision infections were reported within 72 hours in patients who had undergone heart surgeries at the hospital, STAT reports.
“We were able to jump on this pretty quickly. We surveil our patients pretty intensely, and when we had several patients present (symptoms) within a 72-hour period, that set off a red flag right away,” hospital chief medical officer John Heaton told The New Orleans Advocate.
The hospital is paying for treatment of the infections and their related costs, according to STAT News, and has switched from using tap water to filtered water in a new heater-cooler made by a different company.
In February, LivaNova released a field safety notice it sent to customers with its FlexTherm heater cooler device informing them it is voluntarily removing all such devices installed at customer sites over design issues.
Last October, the U.S. Centers for Disease Control & Prevention warned of the risk of serious bacterial infection in open heart surgery patients patients from a device made by Sorin, which merged last year with Cyberonics to form LivaNova.