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Failure at University Hospitals Fertility Clinic Caused by Human Error

In a detailed draft letter to NBC News, the University Hospitals Fertility Center says the remote alarm system in the tank alerted an employee about temperature changes. it was off The center does not know who turned it off, but it was off during the weekend of March 3.

Despite the 11 miscarriages, Wendy and Rick Penniman had two healthy children with the help of the Fertility Center of University Hospitals. But now, there is no hope of using their frozen embryos to have a third child.

"It's devastating, I think, for us, but it's more devastating because it takes something away from our children," said Wendy Penniman, 41.

Christina and Marc Ellis wanted to use their two remaining embryos in the center to give their daughter, now 2 years old, a brother.

"I do not know if I can go through the whole process again, and what will be the result?" Christina Ellis told NBC News.

Wendy and Rick Penniman and their children, Beau and Molly Kate. After Wendy suffered multiple miscarriages, the two sons of the Pennimans were born with the help of the University Hospitals fertility clinic. The couple hoped to have a third child, but they were told that their remaining two frozen embryos are no longer viable. Courtesy of Wendy Penniman

Both couples are now suing. So are at least 16 other groups of plaintiffs, all claiming negligence and breach of contract.

Fault history

And there may be an underlying technical problem, one that has happened before.

An investigation by NBC News found that the manufacturer of this particular storage tank, Custom Biogenic Systems, has a history of prior failures dating back almost 15 years.

In 2003, Rachel Southwood's husband, Andrew, had frozen sperm in the United Kingdom after he was diagnosed with cancer. The couple from Tauton, England, had a child and hoped they could have another.

"He gave the sample and, as far as we knew, we could potentially have more children," Southwood said.

But less than a year later, the freezer that stored his sperm did not work properly, making the sperm no longer viable. Andrew Southwood finally died of cancer.

"They just said there was a technical malfunction with the unit that stored my husband's sperm," said Southwood, who was 30 years old when the malfunction occurred.

In 2003, British regulators warned that freezers manufactured by CBS, a Michigan company, had problems with their automatic filling mechanisms.

"The manufacturer is aware of 21 incidents" in the United Kingdom, regulators said.

"The alert was withdrawn," according to a statement from the Regulatory Agency for Medicines and Health Products of the United Kingdom to NBC News. "The UK supplier informed MHRA that 95% of the devices in the United Kingdom had been returned and updated, the other 5% will be completed in 2006. Therefore, this problem should no longer affect the UK. has not received more reports since September 2005. "

But two years later, after the first time the warning was issued, a similar incident occurred in Gainesville, Florida. Up to 60 male patients, many with cancer, lost stored sperm when a tank manufactured by the same manufacturer failed.

Experts estimate that there are around 500 clinics that specialize in assisted reproduction throughout the country, based on a 2015 report on the state of assisted reproduction by the Centers for Disease Control and Prevention. That report included a list of 451 clinics that provided data and another 35 that did not.

'There is almost no regulation'

The lack of reliable data on procedures and clinics in the United States The states – and the possible problems with their frozen eggs and embryos – have contributed to a 'regulatory vacuum', says Dov Fox, director of the Center for Legal Policy and Bioethics at the University of San Diego.

"There is almost no regulation or supervision of any kind that directly relates to the prevention of errors like these," said Fox, who is working with one of the plaintiffs in the Cleveland case.

"And no it's just fertility clinics, it's sperm banks, egg sellers, subrogation agencies, in all of these areas, we do not know how common mistakes are, because there are no reports, there are no tracking agencies. "

NBC News contacted federal regulatory agencies and organizations that procured accreditation for fertility labs. When the NBC News Research Unit asked who was ultimately responsible, most said it was not them.

The only government agency that told NBC News that it could technically regulate storage tanks is the Food and Drug Administration, or FDA. But because freezers in fertility clinics have not been marketed specifically as medical devices, that's not the case.

Members of the assisted reproduction industry say tank failures like Ohio's would not have been avoided with more regulations.

"The autocomplete tanks still require periodic periodic controls by laboratory personnel to ensure they work properly," said Dr. Alan Penzias, fertility specialist at Boston IVF, an associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School. , and chair of the practice committee of the American Society for Reproductive Medicine, or ASRM.

"I spoke with staff members in my laboratory who informed me that this is common knowledge."

The fear of lawyers may have played a role in arresting broader reports of prior failures in the US. UU., Says Dr. Mark Jutras, director of laboratory and physician at Advanced Reproductive Concepts in Charlotte, NC.

"Generally, institutions are flawed and their lawyers will not allow outsiders to analyze the situation to find the root cause of the problem and how it could have been avoided," Jutras said.

That's little consolation for patients who lost their frozen eggs and embryos at University Hospitals Fertility Center.

"Who else has the tanks?" Wendy Penniman asked. "And how many babies are at risk now while we sit, while we talk?"

The letter from the University Hospitals told the patients that the facility had obtained another storage tank and that it had planned to move frozen eggs and embryos to that extra tank place before the weekend of March 3 but that process had not begun when the fault occurred.

The fertility center offered to pay for treatments for any patient who wants them.

The Ellis are considering that. The Pennimans declined the offer.

CBS provided NBC News with the following statement:

"Custom Biogenic Systems (CBS) is aware of the incident at University Hospitals Ahuja Center in Beachwood, Ohio and is currently in the process of gathering information.

Our goal is to work diligently to support the investigation of what happened and be useful in finding answers in this difficult situation, we continue to trust our products and our people who serve our clients. "

CBS sent a second statement to NBC News on Tuesday night. In it, CBS denied that problems with the autocomplete mechanism constitute a "malfunction" or an underlying "technical problem."

Dr. James Liu, chairman of the Department of Obstetrics and Gynecology at University Hospitals, told NBC News on Tuesday that the fertility center contacted CBS when problems with the tank were discovered several weeks ago.

"They told us that this is how we would do the preventive maintenance of that particular problem, and that we recognize the problem, and that they were aware of that," said Liu.

In their letter to patients, University Hospitals said that preventive maintenance was necessary because the autocomplete system had "difficulty" and "did not work."

In its second statement, CBS questioned the hospital's method of filling the tank with liquid nitrogen during this period.

"The CBS tank is not designed to be filled with liquid nitrogen that is poured into the top of the tank."

In addition, CBS noticed something that the hospital acknowledged in its letter: that the remote alarm system was F. In addition, the company notes: "CBS did not design, manufacture, install or supervise any remote alarm system in the unit."

In a user manual obtained by the Medical Unit of NBC News, the manufacturer dedicates a page set to "Best practices recommended in the industry for the safe storage of samples".

In a section entitled "Why do I need a secondary or backup alarm?", The manufacturer also warns: "Your freezer could malfunction." Having a secondary or backup alarm can minimize the possibility of a loss due to malfunction. ".

Courtney McGee, Jane Weaver, Susan Wagner and collaborator Linda Carroll contributed to this report from NBC News

Editor's Note: This story has been updated to include a statement from Custom Biogenic Systems. The statement was sent to NBC News on Monday by email, but appeared to be spam and was not opened until Tuesday.

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