Events

Safety Alert for Infusion pumps Alaris IVAC (1) Model 597, (2) Model D598

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Alaris Medical Systems Inc.

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
    237
  • Date
    2000-12-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The uk medical devices agency (mda) has issued a safety note informing hospitals that it continues to receive reports of high doses of infusion resulting from user-free flowing by mismanaging the devices of the pumps mentioned. the mda states that poorly handled apparatus can interfere with the pump mechanism, resulting in a free flow at the start of the infusion. while the infusion happens the assembly positions correctly and the fluid adjusts to the set of programmed instructions. the mda states that in such cases, even if the user can detect the high doses of infusion by examining the amount of fluid in the bag, the inadequate loading will not be detected, since the assembly will not be properly positioned. in addition, the infused volume display will not show the wrong extra volume due to the initial free-flow.
  • Action
    MDA recommends the following: (1) Ensure that the assembly loading instructions are followed at the time of fitting of the equipment in the Pump Models 597 and 598. (2) Do not operate the orange lock before the lower set adapter is fully inserted into the air-in-line switch. (3) Do not close the door before operating the orange latch. (4) Make sure that no fluid is present and that no drop is dripping into the chamber at the time of opening of the assembly clamp prior to the start of infusion. For further factory information, contact your local representative or directly with Carlos Sepulveda, Alaris Medical Systems, by mail at the above address, by phone / fax 0021-44-2- (125) 633 0860 ..

Device

Infusion pumps Alaris IVAC (1) Model 597, (2) Model D598

Manufacturer

Alaris Medical Systems Inc
  • Source
    ANVSANVISA