Safety Alert for Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Fan Pressure and Volume. ANVISA registration number: 10349000483. Class of risk: III. Affected Model:. Serial numbers affected: 1438MM0489

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Auto Suture do Brasil Ltda.; Covidien LLC.

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
    2421
  • Date
    2017-12-05
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    • Immediately notify all treatment centers where the PB980 fans are used on this notification. • If your installation has distributed the PB980 fans to other people or institutions, immediately forward a copy of this letter to these recipients. • Complete the attached form and return it as directed to confirm your receipt and understanding of this information. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 01/12/2017 - Date of notification notice to Anvisa: 12/5/2017 The company holding the registration of 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
    A functional battery installed in the pb980 fan automatically recharges when it runs out and the fan is connected to ac power. in the case of a battery with incorrect firmware, its full charge may fail. this situation does not impact the operation of the fan when it is connected to the ac mains. however, if the fan is operated only on battery power, this situation could limit the amount of fan operation time. • during battery-powered ventilation, an alarm will sound when only 10 and 5 minutes of battery power remain. • in the rare event of a total power failure, an alarm alerts the operator that there is insufficient power and no ac power to allow fan operation. the alarm will sound for at least 120 seconds while the fan power switch is in the on position. there are no reports of this occurrence.
  • Action
    Field Action Code Puritan FA triggered under the responsibility of the company Auto Suture do Brasil Ltda. It will make Correction in the field.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA