Tainted intravenous bags sold to US health clinics

Hundreds of bags of intravenous saline solution meant for training health care workers have been given to real patients http://www.nytimes.com/2015/01/16/science/earth/fda-begins-inquiry-after-death-and-illnesses-from-saline-bags-meant-for-training.html?ref=us
Health authorities were scrambling to answer this week after Wallcur, a San Diego-based company, recalled different-size bags of its saline solution and distilled water on Jan. 7.
As of Thursday, 17 patients had fallen ill and one person — a hospice patient — had died after being given the solution, health officials said, though they could not say conclusively whether the saline solution was the cause. Patients in seven states reported symptoms, including chills, fever, tremors and headaches.
The company said it began shipping the saline, in bags labeled “for clinical simulation,” on May 22, 2014. It said the products were not intended for people or animals because they were not sterile.
The Food and Drug Administration, which is investigating the case, said the bags had been shipped to medical clinics, surgical centers and urgent care facilities, some of which administered them to patients.
Dr. Alexander J. Kallen, a medical officer at the Centers for Disease Control and Prevention, said its investigators had traced the saline in question to a distributor, a company that officials have not yet named. About 50 clinics received the products, he said.
He said it was still unclear whether the bags, which he estimated to be in the hundreds, were shipped in error, or whether clinic workers ordered them without understanding that they were for training.
“It seems like it’s not just one single mistake,” Dr. Kallen said. “There could have been instances where ordering was done by office staff who didn’t know the difference, as well as instances where the right product was ordered but they received the wrong stuff.”
Paul Delmore, a lawyer for Wallcur, said the company makes only training products and sells to clients such as nursing schools, not to hospitals or clinics. But it also sells through separate distribution companies. Mr. Delmore said Wallcur does not know who buys from those distributors. He said all of the symptoms were linked to shipments ordered through a distributor, not directly from Wallcur.
“There’s nothing intrinsically wrong with the product,” he said. “It was apparently sent to a facility it should not have been sent to.”
The medical industry uses products made to look like real IV bags and syringes,
for example, to train health workers. They are used in demonstrations or on
dummies, and are sometimes cheaper than the real thing.

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