Events

Safety Alert for Trade name: Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 80113010024. Risk class: III. Model Affected: Infusion Pump GH / Infusion Pump PK. Serial numbers affected: pumps manufactured prior to September / 2008 - attached list.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Respiratory Care Hospitalar LTDA.; Carefusion Switzerland 317 Sarl..

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
    2408
  • Date
    2017-11-16
  • 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
    If a pl3 alarm occurs the syringe pump should be immediately withdrawn from clinical use and should be referred for repair by qualified service personnel or authorized technical assistance. Additional information: - Date of identification of the problem by the company: 06/11/2017 - Date of notification notice to Anvisa: 11/16/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    Error code pl3 is an alarm indicating that the equipment is malfunctioning. alarm pl3 causes the device to stop working and warns the user of an internal fault by sending an error message together with a light signal and a steady high alarm that can not be silenced.
  • Action
    Field Action Code PL3-ALARM triggered under the responsibility of Respiratory Care Hospitalar LTDA. Will make the Notice to the client.

Device

Trade name: Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 80113010024...

Manufacturer

Respiratory Care Hospitalar LTDA.; Carefusion Switzerland 317 Sarl.