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CALL7 Investigation: Recalled Baby Warmers At Local Hospital

Babies Could Be Burned, Investigation Prompts Changes

-ABC News

09/22/2009 - DENVER -- Swedish Medical Center boasts state of the art care, but the CALL7 Investigators found the hospital still using recalled baby warmers months after warnings and recalls were made public.

The recalls were the a result of an incident at a Minnesota hospital in January 2008.

Maverick Werth, just hours old, was placed into what is called a Hill-Rom Stabilet when it burst into flames.

Despite strongly worded warnings over the past nine months from national safety experts, the manufacturer and the U.S. Food and Drug Administration, the CALL7 Investigators found Swedish Medical Center routinely using the warmers with no warning to parents.

"That's what I'm asked to do every time I go to work, to put infants in danger," said a source at Swedish, who asked to remain anonymous.

"We're talking about babies potentially catching fire ...," said CALL7 Investigator Theresa Marchetta.

"It's pretty horrific," the employee replied.

The employee said placing the infants on the recalled warmers was a cause for worry every day.

"I wouldn't want to put anyone else's baby at risk," said the employee.

That risk involves a piece of equipment called a Hill-Rom Stabilet model 1250, an infant warmer found after lengthy investigation to be the likely cause of a fire that severely burned Maverick when he was just 11 hours old in January 2008.

Mercy Hospital's investigation found "hot particle falling from the bassinet's warmer assembly into the oxygen enriched environment near the infant's head" sparked the fire that burned Maverick.

On Feb. 4, Emergency Care Research Institute, or ECRI, the primary investigator of the incident, published a high priority alert urging hospitals to "remove from service" and "render unusable" the Hill-Rom Stabilet model 1250 along with any similar models.

On July 20, the FDA and the manufacturer issued a "Class 1 Recall" warning hospitals "the out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire," and that continued use of the warmers risks "serious injury or death."

"When was the first time employees were told about this risk for fire?" Marchetta asked the Swedish employee.

"About a month ago. We were told we were getting new warmers, but not why," the source said.

"Did you get the warmers?" asked Marchetta.

"No," responded the employee.

In an e-mail obtained by the CALL7 Investigators, director of Women's Services at Swedish, Janet Dyer, notified only labor and delivery employees about the recall more than one month after the FDA and manufacturer recall was issued and eight months after the first alerts were made public.

The e-mail warned, "O2 and heat cannot be run simultaneously on any of the recalled beds which are still in some rooms."

Dyer also wrote, "We are trying to move the 'good' equipment to areas where both will be required simultaneously," and "Maybe by Halloween, if all goes well, we will be fully functional again."

"What are you thinking at that moment you're told to keep using them?" Marchetta asked the employee.

"That every time I attend a delivery it makes me worry. What if something happens to this baby or myself? But mostly I can't live with myself if something happened to someone I'm supposed to be taking care of. How could I face those parents?" the employee said.

The employee said supervisors at Swedish failed to warn employees in other departments, like respiratory therapists and midwives, who routinely turn on the oxygen and heat at the same time on the recalled warmer when attending to infants, because they were never warned of the danger.

During a phone conversation on Sept. 8, Dyer said there was no need to tell anyone else because, "No one else uses them, only labor and delivery." Dyer also said, "There is no dangerous equipment in use," and accused fellow employees of being "sensationalists" who are "always trying to rock the boat" by coming forward.

"A fire of this type should not have occurred and should never occur again. For a hospital now to be using these eight or nine months after the initial recall, and then the manufacturers recall, is not justified," said Mark Bruley, vice president of accident and forensic investigations for the ECRI Institute in Pennsylvania.

Bruley lead the investigation when the baby was burned in Minnesota and published the findings that triggered the recall. He said hospitals should have acted on the information immediately.

"If they are using it and a child is delivered oxygen and a fire occurs then the hospital is in an almost indefensible position," said Bruley.

Swedish Medical Center denied repeated requests by the Call7 Investigators for an on-camera interview.

In an e-mailed statement, the hospital admitted to having knowledge of the recall in July, but denied patients were put in danger.

" Swedish Medical Center received a recall notice from Draeger Medical Inc. and the Food and Drug Administration (FDA) in late July 2009 regarding the use of the Draeger Stabilet Infant Warmer. Recall notifications are taken seriously and followed carefully by Swedish Medical Center. Swedish immediately began taking the necessary steps to ensure patient safety by following all manufacturer recommendations. As such, at no time has any patient been put at risk with the use of an infant warmer at Swedish.

With patient safety as the number one priority, Swedish immediately began using alternate warmers unaffected by the recall in addition to a small number of affected warmers. The affected warmers are being operated only within the safety guidelines detailed by the manufacturer in the recall. The affected warmers will be taken completely out of service when replacement warmers arrive."

On Monday, Sept. 21, Swedish sent this update to their statement.

"We were using unaffected warmers whenever possible, and labeled all of the affected warmers and educated staff about the restrictions as outlined in the recall. As of last week, all of the affected warmers were removed from service and replacement warmers will arrive this week."

"Would you have a baby at Swedish Hospital?" asked Marchetta.

"Not if they're going to use that warmer," the employee said.

"What do you think about Swedish using this type of equipment in any form?" Marchetta asked an expectant mother due to give birth at Swedish within weeks.

"If they know they're doing it, it upsets me," she said.

She also said she was never told about the recalled warmers.

"I did not carry this child for almost 10 months for a hospital to burn it. I need to trust them to take care of my child," she said.

The Call7 Investigators asked other metro area hospitals if they use Hill-Rom Stabilets.

Denver Health, Rose, St. Luke's, Avista, Aurora Medical Center Littleton, Parker, Penrose-St. Francis, Porter, St. Anthony, North Suburban, Sky Ridge, Children's, Centura, University of Colorado, Exempla St. Joe's and Lutheran replied and said they did not use the recalled baby warmers.

Boulder Community Hospital said it had two units that were taken out of service as soon as they received the recall notice.

If you or your infant has suffered injury or loss due to a defective Stabilet infant warmer you may be entitled to compensation. Contact theStabilet infant warmer lawyers of Ennis & Ennis, P.A. today by filling out the Case Evaluation Form on this page or call toll-free: 1-800-856-6405. Nationwide Free Legal Consultations.