Events

Safety Alert for MedSystem III Infusion Pump

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
    366
  • Date
    2001-12-30
  • 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
    A hospital member of ecri reported that the low dosage can only be programmed within the pump calculator is 0.1mcg / kg / min; however, some of these drugs used (eg, fenoldopam, isoproterenol, norepinephrine) have a dosage range below 0.1 mcg / kg / min.
  • Action
    For most infusions, the drug dose calculator on the MedSystem III infusion pump has sufficient resolution; however, for doses below 0.1 mcg / kg / 1min, the calculator should not be used. In these cases, the clinician should use another calculator with sufficient resolution and then place the correct measurement on the pump. In cases where these calculations must be done regularly an appropriate backup calculator should be well on hand. In addition, whenever a user does the calculation manually, another team member should confirm them before programming the pump. For more information, contact ANVISA's Technovigilance Unit, by phone at (61) 448-1485. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

MedSystem III Infusion Pump

Manufacturer

ALARIS Medical Systems Inc
  • Source
    ANVSANVISA