Events

Safety Alert for BLOOD LINE FOR HEMODIALYSIS MACHINES. Bloodlines - Medisystems Corp., product code: D3-9694 / 9793 or K3-9694 / 9793, Baxter product code 5M9694.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Healthcare Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    674
  • Date
    2002-09-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    BRAZIL - 24.09.2002 (12:17 h) - ANVISA is conducting the survey if the product is registered nationwide. BRAZIL - 06.11.2002 - To date, Meridian products (dialysis machine) and blood, arterial and venous lines of Medisystems are not registered in Brazil and therefore are not marketed in this country. In this way, the recall announced by the FDA on 12.09.02 did not reach Brazil. (Baxter)
  • Reason
    Some blood lines used with baxter meridian dialysis machines may possibly be linked to five patient deaths and two injuries. the incidents occurred at the nephrology clinic, inc., mishawaka, and ind., and physicians dialysis, inc., grand rapids, mich. baxter's preliminary investigation found that in the two hemodialysis centers where the incidents occurred, the following may have been used: blood lines - medisystems corp., product code: d3-9694 / 9793 or k3-9694 / 9793, code of baxter's 5m9694 product. hemodialysis machine - meridian medisystems alternative blood lines are available.
  • Action
    The cause of the deaths has not yet been definitively determined, Baxter on September 6 notified the hemodialysis centers that they are exploring the possibility that hemodialysis treatments in patients may have used the same model of dialysis machine and line array blood. Baxter advised customers to immediately discontinue use of certain Medisystem bloodline models in conjunction with Meridian dialysis machines and request that they use other Medisystems bloodlines.

Device

BLOOD LINE FOR HEMODIALYSIS MACHINES. Bloodlines - Medisystems Corp., product code: D3-9694 / 979...

Manufacturer

Baxter Healthcare Corporation
  • Source
    ANVSANVISA