Events

Safety Alert for Trade name: Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 80113010024. Risk class: III. Model Affected: N / A. 135002842; 135002843; 135002844; 135002845; 135002846; 135002847; 135002848; 135002849; 135002850; 135002851; 135002852; 135002853; 135002854; 135002855; 135002856; 135002857; 135002858; 135002859; 135002860; 135002861; 135002862; 135002863; 135002864; 135002865; 135002866; 135002867; 135002868; 135002869; 135002870; 135002871; 135002872; 135002873; 135002874; 135002875; 135002876; 135002877; 135002878; 135002879; 135002880; 135002881; 135002882; 135002883; 135002884; 135002885; 135002886; 135002887; 135002888; 135002889; 135002890; 135002891; 135026271; 135029940; 135044964; 135044977; 135044984; 135044987; 135044988; 135044989; 135044990; 135044991; 135044994; 135044996; 135044997; 135044998; 135044999; 135045018; 135045021; 135045027; 135045031; 135045035; 135045867; 135045873; 135045877; 135045881; 135045883; 135045884; 135045885; 135048038; 135048039; 135048040; 135048041; 135048042; 135048043; 135048045; 135048047; 135048048; 135048053; 135048054; 135048055; 135048057; 135048058; 135048059; 135048060; 135048061; 135048062; 135048064; 135048067; 135048069; 135048071; 135067003; 135067004; 135067005; 135067006; 135067008; 135067010; 135067012; 135067013; 135067014; 135067015; 135067017; 135067019; 135067021; 135067023; 135067024; 135101756; 135101757; 135101758; 135101759; 135101760; 135101761; 135101762; 135101763; 135101764; 135101765; 135101766; 135101767; 135101768; 135101769; 135101770; 135101771; 135101772; 135101773; 135101774; 135101775; 135101776; 135101777; 135101778; 135101779; 135101780; 135177845; 135180716; 135180717; 135180718; 135180719; 135180720; 135180721; 135180722; 135180723; 135180724; 135180725; 135180726; 135180727; 135180728; 135180729; 135180730; 135180731; 135180732; 135180733; 135180734; 135180735; 135180736; 135180737; 135180738; 135180739; 135180740; 135180741; 135180742; 135180743; 135180744; 135180745; 135180746; 135180747; 135180748; 135180749; 135180750; 135180751; 135180752; 135180753; 135180754; 135180755; 135180852; 135180853; 135180856; 135180857; 135180858; 135180859; 135180860; 135180861; 135180862; 135180863; 135180864; 135180865; 135180866; 135180867; 135180868; 135180869; 135180872; 135180873; 135180874; 135180875; 135180876; 135180877; 135180878; 135180879; 135180880; 135290455; 135309499; 135309500; 135309501; 135309502; 135309503; 135309504; 135309505; 135309506; 135309507; 135309508; 135309509; 135309510; 135309511; 135309512; 135309513; 135309514; 135309515; 135309516; 135309517; 135309518; 135309519; 135309520; 135309521; 135309522; 135309523; 135309524; 135309525; 135309526; 135309527; 135309528; 135309529; 135309530; 135309531; 135309532; 135309533; 135309535; 135309536; 135309537; 135309538; 135309539; 135309540; 135309541; 135309542; 135309543; 135309544; 135309545; 135309546; 135309547; 135309548; 135335853; 135335854; 135335855; 135335856; 135335857; 135335858; 135335859; 135335860; 135335861; 135335862; 135335863; 135335864; 135335865; 135335866; 135335867; 135335868; 800223130; 800223141; 800230698; 800246367; 800246486; 800246492; 800246494; 800246495; 800246503; 800246504; 800246513; 800246519; 800246520; 800253306; 800253452; 800253706; 800253708; 800253709; 800253756; 800253758; 800253770; 800253773; 800253790; 800253886; 800253887; 800253888; 800253890; 800253891; 800253893; 800253894; 800253897; 800253898; 800253899; 800254037; 800254038; 800264156; 800264407; 800265147; 800265148; 800265149; 800265150; 800265151; 800265152; 800265153; 800265154; 800265155; 800265156; 800265157; 800265159; 800265160; 800265163; 800265167; 800265169; 800265170; 800265172; 800265175; 800265177; 800265179; 800265180; 800265181; 800265182; 800265185; 800265187; 800265193; 800265202; 800265203; 800265208; 800265209; 800265210; 800265211; 800265215; 800265216; 800265217; 800265219; 800280535; 800280569; (...)

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 305 Uk Ltd/Bd Switzerland 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
    2375
  • Date
    2017-09-06
  • 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
    Spring exchange. High priority should be given to clinical areas of neonates, pediatrics and critical care areas where critical drugs are administered at low infusion rates. If the plunger spring breaks, the pump will alarm "CHECK THE SYRINGE" and in this case be withdrawn from use until the spring is replaced. Spring replacement every 3 years of use of the pump as a preventive maintenance item. Special attention should be given to pumps for more than 3 (three) years from the date of manufacture. To identify the age of the pump, see the label on the back, where it is possible to check the date of manufacture. 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: 08/30/2017 - Date of notification notice to Anvisa: 09/09/2017 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
    Based on reports received from a customer in late 2016, bd / carefusion has identified a potential risk of syringe siphoning when used with alaris syringe pumps that have broken "plunger support spring". this spring is located located within the plunger support assembly.
  • Action
    Field Action Code RA-2017-02-02 triggered under the responsibility of Respiratory Care Hospitalar Ltda. Field correction. Cont. batches affected: 800280605; 800280611; 800288773; 800289064; 800289121; 800289123; 800289124; 800289125; 800289128; 800289129; 800289130; 800289131; 800289133; 800289145; 800289155; 800289160; 800289165; 800289186; 800289226; 800289273; 800289274; 800289906; 800289963; 800289964; 800289974; 800289983; 800289986; 800290041; 800290185; 800290211; 800290238; 800290255; 800290258; 800290259; 800290261; 800290264; 800290267; 800290276; 800290278; 800290280; 800290281; 800290290; 800290293; 800290297; 800290298; 800290302; 800290309; 800290310; 800290313; 800290336; 800290338; 800290359; 800502728; 800504356; 800504358; 800504359; 800504363; 800504368; 800504378; 800504393; 800504399; 800504400; 800504404; 800504409; 800504414; 800506052; 800506152; 800506384; 800506393; 800506395; 800506396; 800506403; 800506406; 800506407; 800506409; 800506410; 800506411; 800506417; 800506418; 800506421; 800506426; 800506431; 800506433; 800506434; 800506435; 800506437; 800506441; 800506444; 800506448; 800506450; 800506453; 800506456; 800506457; 800506459; 800506461; 800506462; 800506463; 800506464; 800506467; 800506469; 800506471; 800506473; 800506474; 800506475; 800506476; 800506477; 800506480; 800506483; 800506484; 800506485; 800506488; 800506490; 800506491; 800506493; 800506494; 800506495; 800506497; 800506499; 800506500; 800506501; 800506502; 800506504; 800506505; 800506506; 800506508; 800511629; 135048046; 135048049; 135048066; 135048070; 135067000; 135067001; 135067002; 135067007; 135067009; 135067011; 135067016; 135067018; 135067020; 135067022; 800206637; 800208407; 800208478; 800208512; 800208532; 800208568; 800208591; 800208631; 800208644; 800208686; 800208736; 800214012; 800214015; 800214028; 800286101; 800510954; 800510957; 800510960; 800510973; 800510975

Device

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

Manufacturer

Respiratory Care Hospitalar Ltda; Carefusion 305 Uk Ltd/Bd Switzerland Sarl
  • Source
    ANVSANVISA