Events

Safety Alert for Trade name: i-STAT KAOLIN ACT CARTRIDGE. Technical Name: Activated Coagulation Time. ANVISA registration number: 80146501500. Risk class: III. Affected Model: Not applicable. Serial Numbers Affected: R16354A; R17025; R17041; R17080; R17110; R17123; R17165; R17197; R17201A; R17197A; R17273; R15310; R15356; R16034; R16067; R16115; R16146; R16174; R16222; R16254; R16278; R16304; R16316; R17007; R17038; R17059; R17128; R17201; R17250; R17276; R17321

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

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
    2480
  • Date
    2018-01-23
  • 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
    The Kaolin ACT i-STAT test is not significantly prolonged in the presence of a therapeutic level (200-280 KIU / mL aprotinin (Trasylol)). If a patient received the maximum dose of aprotinin of 400 KIU / mL, Abbott Point of Care recommends that the first blood sample after drug administration be collected after 15 minutes to ensure full drug delivery and to achieve a concentration therapy. If you have forwarded any i-STAT Kaolin ACT cartridges to another laboratory, please provide a copy of this notice to the laboratory in question. 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: 12/19/2017 - Date of notification notice to Anvisa: 01/23/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. 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
    The drug aprotinin (trasylol), previously withdrawn from many markets, but which may be available in some countries / regions, may be administered during cardiopulmonary bypass (cpb) surgery, as it has been shown to reduce post-operative bleeding in patients cardiac surgery mainly related to the inhibition of fibrinolysis and platelet activation. by internal studies abbott point of care has identified that the kaolin act i-stat test can be extended immediately following administration of an initial complete dose of aprotinin bolus of 400 kallikrein (kiu) inhibitor units / ml. once the drug has been fully distributed throughout the body, there is no impact on the reported act result. for aprotinin, 200-280 kiu / ml is considered a therapeutic concentration or stable state during cpb surgery. the decision to use aprotinin and the dosage that a patient receives are determined on a case-by-case basis, considering the type of procedure, the expected length of cpb surgery, whether the patient has ever been exposed to aprotinin in a procedure, and the patient's weight / size ; therefore, not all cardiac procedures use aprotinin and most patients receiving aprotinin receive a therapeutic dose.
  • Action
    Field Action Code APOC2017-008 triggered under the responsibility of Abbott Laboratórios do Brasil Ltda. It will interact with drug aprotinin (Trasylol).

Device

Trade name: i-STAT KAOLIN ACT CARTRIDGE. Technical Name: Activated Coagulation Time. ANVISA regis...

Manufacturer

Abbott Laboratórios do Brasil Ltda; Abbott Laboratories
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA