UPDATED Sept. 17, 2018, with comment from Haemonetics.
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.
A Haemonetics spokeswoman told MassDevice.com via email that the problem, limited to France, stems from a disposable used during the apheresis process and “does not relate to the use of Haemonetics plasma collection machines with other Haemonetics disposables.”
“The ANSM’s decision and the two reports have no relation whatsoever to the use of refurbished parts. The concerned disposables are single-use devices and as such cannot contain refurbished parts. We consider it critical not to create any confusion that may cause distress to patients and donors,” the company said in an emailed statement. “Haemonetics wants to reassure all users of our apheresis devices that these are isolated reports which have been correctly monitored through the French materiovigilance system, and that in both instances there were no reported injuries to donors or patients. This matter is limited to France and we are actively working on our options to send replacement kits to France for use with our plasma collection machines so that our customers can resume collections.”
The Braintree, Mass.-based company stressed that it was not given access to examine the reported incidents, noting that its response so far was “based only on photos of the machine, device and plasma bag.”
“In the absence of access to the device for a root cause analysis, the implicated machine has been quarantined as a precautionary measure as requested by the health authorities,” the company said.