KU Med staffer admits in trial that halt in disinfection fueled deadly infection
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- Newberry decided on Oct. 16, 2018, to stop disinfecting the heater‑cooler units.
- The heater‑cooler used in Stephen Nolte’s surgery hadn’t been disinfected in five months.
- More than two dozen lawsuits allege 25 KU Med patients contracted M. chimaera infections.
The University of Kansas Hospital staffer in charge of the open-heart surgery devices that have been linked to a brutal and sometimes deadly infection was in the hot seat in a Kansas City, Kansas, courtroom on Friday.
David Gross, an attorney for LivaNova USA Inc. — the medtech company that manufactured the devices — said Jamie Newberry, KU Med’s chief perfusionist, stopped disinfecting the heater-cooler units even though the hospital had been warned that they could be contaminated.
The Food and Drug Administration, Gross said, told Newberry that there was a risk of death if the devices weren’t disinfected.
“For whatever reason,” he said, raising his voice at Newberry, “you didn’t do that.”
The testimony came on day five of a trial in Wyandotte County District Court over the allegation that a contaminated heater-cooler device used during a Raytown man’s surgery led to the infection that claimed his life.
Stephen Nolte underwent an aortic valve replacement at The University of Kansas Hospital on March 6, 2019, and died of Mycobacterium chimaera, or M. chimaera, on July 8, 2020. He was 71.
The trial is expected to last about three weeks, but attorneys told District Court Judge Courtney Mikesic on Friday that they were hoping to get to closing arguments by the end of this week.
Nolte’s widow, Christine, and their son, Christopher, filed a lawsuit in 2021 against The University of Kansas Hospital Authority and LivaNova USA Inc.
The lawsuit alleged wrongful-death and personal injury claims against The University of Kansas Hospital Authority and negligence and product liability claims against LivaNova.
The University of Kansas Hospital Authority settled shortly before the trial, and Mikesic approved the confidential settlement on April 13, dismissing KU Med as a defendant. According to a court filing, no admission of liability was made.
Nolte’s case is among more than two dozen lawsuits that The Star reported last month have been filed in Wyandotte County District Court against The University of Kansas Hospital Authority and LivaNova.
The lawsuits allege that 25 patients at The University of Kansas Hospital contracted the M. chimaera infection after undergoing open-heart surgery involving heater-cooler devices that hadn’t been properly disinfected.
In those cases, 11 of the patients died, and others are living with life-altering health problems, according to the lawsuits. About 17 of the cases have resulted in confidential settlements with The University of Kansas Hospital Authority, court filings show.
A large jug of Clorox and some hydrogen peroxide
On Friday, Gross talked about five new “loaner” units that had been delivered to KU Med to replace its older ones after contamination issues surfaced. He said Newberry had signed a document in May 2017 stating he understood there could be contamination risks involved even with the new machines, but that the benefits outweighed the risks.
Gross read from an FDA document that said M. chimaera infections from the heater-cooler devices were rare and hard to detect because a patient may not develop symptoms for years. But the FDA said the devices were important for patient care and that their benefits outweighed the risks of infection transmission. The FDA also said that hospitals should continue to strictly adhere to maintenance and disinfection procedures, Gross said.
KU Med received the new units in June 2017, he said, and they were “up and running” the first week of July 2017.
A heater-cooler device contains pumps that circulate water during bypass procedures to regulate a patient’s temperature.
The units are used in conjunction with a heart-lung machine, which takes over the function of the heart and lungs during surgery. Studies found that in contaminated heater-cooler devices, the aerosolized vapor is pushed out of the water tanks by exhaust fans, spreading bacteria through the air in the operating room. That bacteria can then enter a patient’s open cavity, leading to infection.
During his cross-examination, Gross raised issues about other possible sources of infection at KU Med. He said that in August 2017, testing of the water in the sinks and ice machines in the cardiothoracic surgery area found that the filters on the ice machines had expired. He asked Newberry how that could have happened. Newberry said he was not in charge of those areas.
Water testing in October 2017 showed possible contamination in the water faucets, Gross said. He noted that in February 2018, staff started flushing out all the sinks at the beginning of each day.
Gross asked Newberry if it was his understanding that the water could have been contaminated. Newberry said yes, but added that hospital water wasn’t used in the heater-cooler tanks. The tanks were filled with filtered water, he said.
On Oct. 16, 2018, Newberry decided to stop disinfecting the heater-cooler devices with bleach every two weeks and putting hydrogen peroxide in the water tanks — instructions LivaNova had said should be strictly adhered to. Instead, he instructed the staff to drain the water tanks every day.
Gross said Newberry let LivaNova know that they were draining the tanks daily, but didn’t tell them that the hospital staff had stopped disinfecting them.
Gross held up a large jug of Clorox bleach and a brown bottle of hydrogen peroxide to show the jury what was used for disinfecting, then played a short video on how the process worked.
Newberry said it took about an hour to disinfect one heater-cooler device. He said the KU Med perfusionists would place industrial strength Clorox in the tank and run it through, then refill the tank and drain it two more times to make sure all the bleach was gone. After that, they filled the tank again and added hydrogen peroxide — “the same stuff you buy at CVS,” he said.
‘At no point did you raise an alarm’
As Gross grilled Newberry, he noted at one point that the Nolte family was in the courtroom.
“I understand the subject matter is sensitive,” he said, but added that it was necessary for him to go through the timeline of events.
He described an email from a perfusionist who worked with KU Med that was dated Oct. 29, 2018, one day before the two-week disinfection should have taken place. The perfusionist questioned the decision to stop disinfecting the units, saying his concern with draining was that if the tanks weren’t completely dry and still contained moisture, bacteria could form.
Gross said halting the disinfection process was in direct conflict with instructions from the FDA, the Centers for Disease Control and Prevention, and LivaNova. But Newberry didn’t consult with anyone at KU Med, he said.
The heater-cooler device used in Nolte’s surgery hadn’t been disinfected in five months. And when infections started surfacing in open-heart surgery patients, Gross said to Newberry, “At no point did you raise an alarm.”
Newberry did not let anyone know that they had stopped disinfecting the units even though they’d been warned to continue doing so, Gross said.
In October 2019, Gross said, as it became clear that there was an issue with M. chimaera infections in heart surgery patients, Newberry was asked if there was anything KU Med needed to do differently to address the problem.
He said Newberry responded: “This is truly confounding. We have not changed anything on our end.”
Newberry said in court that he meant “we hadn’t changed anything we were currently doing.”
Matt Birch, an attorney for the Noltes, asked Newberry whether he disputed that the decision to stop disinfecting the machines every two weeks contributed to Nolte’s M. chimaera infection.
“That seems to be the case,” Newberry said quietly. “No, I don’t dispute it.”
In addition to not disinfecting the machines, Birch asked Newberry, didn’t the presence of bacteria in the units also contribute to the infection outbreak?
“Correct,” Newberry said.
As for the expired filters in the ice machines — an issue that Gross said was discovered again in August 2019 — Birch asked Newberry whether ice was ever placed in the heater-cooler tanks. Newberry said it was not.
Birch then asked Newberry if he’d ever seen a surgeon take ice from the machines and put it into the open chest of a patient during heart surgery.
“Absolutely not,” Newberry said.
When KU Med got the new heater-cooler units from LivaNova, Birch asked Newberry, did he believe they were free of M. chimaera?
“I believed that was true,” Newberry said. “That was the purpose of swapping the machines.”
And if he’d known that the machine used in Nolte’s surgery was contaminated with M. chimaera, Birch asked, would he have stopped disinfecting it?
“No,” Newberry said. “I would not have stopped if that was the case.”
