LifeCare Plum A + Infusion Pump / ANVISA Registration # 80253310023 의 안전성 경고

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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.

Infiltration of liquid may result in pump inability to recognize installed cassettes, cause valve cassette test failures, or generate one or more of the following error codes: E / N180, E / N181, E / N186, E / N187 , E / N250, E / N251 or E346, which may cause an interruption in pump configuration or interrupt infusion. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. Delay or interruption of therapy, in the worst case, can cause a serious injury or serious adverse events. Health professionals are advised to assess the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should consider contacting a Hospira representative for the use of an alternate pump, particularly for patients in whom delayed / discontinued therapy can lead to serious injury or serious adverse events. A visual inspection of the subsystems of the device by the trained person can determine if liquid has occurred and the performance of the infusion pump has negatively impacted. Until the pumps are inspected, if you are having abnormal reports with the error codes mentioned, remove the pump from use and contact Hospira to report the problem. Hospira reminds users to clean the pump as instructed in the Plum A + pump operating manual, including: - taking precautions to prevent cleaning solutions from saturating in-line air detectors or entering the pump during cleaning of line detectors - avoid spraying cleaning solutions in the direction of any pump opening. Access to the letter, see the link: http: //portal.anvisa.gov.br/wps/wcm/connect/f3e1d3804f8619b3b3ecf79a71dcc661/5+-+FA212-05_Carta+Clientes.pdf? MOD = AJPERES UPDATE: 12/01/2014 - up to the present moment, has been satisfactorily fulfilling the field actions related to the cited product, as proposed in the action plan. It should also be noted that according to the reports sent to this ANVISA the company has already updated 4,847 units, which represents 79% of the installed plant in Brazil (total of 6,129 pumps). ////// UPDATE 12/01/2015: RESOLUTION-RE Nº 4.944, OF DECEMBER 26, 2014 Partially repeal Resolution RE 1839 of 05/22/2013, published in DOU Nº 98 of 05/23 / 2013, section 1 pg.65, releasing the importation of infusion pump LIFECARE PLUM A +, registration no. 80253310023, owned by Hospira Produtos Hospitalares (CNPJ 0628311 / 0001-89). #### UPDATED ON 08/23/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.