Health problems with blood plasma machines

Response to this request is long overdue. By law, under all circumstances, Health and Food Safety should have responded by now (details). You can complain by requesting an internal review.

Dear Health and Food Safety,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting information.

The French regulator l'Agence nationale de sécurité du médicament et des produits de santé (ANSM) made on 12 september 2018 the decision to suspend all medical devices for plasma apharesis, referred to as 782HS-P-SL, manufactured and put on the market by the American company Haemonetics.See
The usage of the machines MCS+ and PCS2 with these devices was also suspended because of the health risks for donors.

In that respect I am requesting documents which contain the following information:

- all communication between member states on EU level with regard to problems with blood plasma machines of Haemonetics;
- all adverse events and/or warnings and/or incidents with blood plasma machines of Haemonetica shared within the EU in the last ten years.

Yours faithfully,

Jeroen Wester
Investigative report NRC Handelsblad
The Netherlands