France suspends blood collection using Haemonetics devices

The French government reportedly decided on a precautionary suspension of the use of a blood collection device made by Haemonetics (NYSE:HAE) – used in half of all donations there – after receiving numerous reports of problems with the devices.

Apheresis devices are used to separate plasma from blood and then return it to the donor. In May, a trio of whistleblowers that includes a former Haemonetics employee lodged official complaints with blood donation overseer l’Établissement Français du Sang and France’s FDA equivalent, l’Agence Nationale de Sécurité du Médicament, according to Connexion France. The complaint alleges that the company’s apheresis devices risk exposing donors to possible cancerous substances and micro- or nano-sized particles of compounds including phenol-formaldehyde resin or aluminium trioxide.

The former employee, Alexandre Berthelot, left the company in 2015. At a May press conference Berthelot alleged that Haemonetics sends older machines back to the U.S., where they are refurbished and then sold “as if they were new,” according to the website.

Now more than 300 of the Haemonetics devices have been taken offline by the ANSM, after the agency received two reports of black particles “of an unusual quantity and size” appearing inside the device and in the plasma collection bag. The French safety watchdog said that so far this year it received 49 reports “relating to noise during the collection process,” citing “recurring atypical incidents despite security measures already in place,” the site reported. There was no incidence of injury or death associated with the problems, according to EFS medical director Dr. Sylvie Gross.

“This situation has only been seen in the French market. ANSM’s decision has no link to our use of second-hand materials or machines,” Haemonetics told Connexion France. The company did not immediately reply to a request for comment.

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