Safety Alert for LifeCare Plum A + Infusion Pump / ANVISA Registration # 80253310023

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.

The main cause of this problem is a degraded battery that no longer has the ability to retain power to be fully recharged. The error code is accompanied by an audible alarm and a visual message on the equipment screen. If E321 error code occurs during infusion, the device stops the process, which can cause delay / interruption in therapy. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. When this error code appears, the pump must go through a power cycle (off and on) to eliminate the error. In addition, the pump must be connected to an AC power source for 8 hours to complete another full charge cycle. If error code E321 appears again after the charge cycle, remove the pump from use, contact Hospira to report the problem, to which service representative replace the battery. Delay or interruption of therapy, in the worst case can cause a serious injury or serious adverse events. Health professionals are advised to evaluate the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should contact a Hospira representative for the use of an alternative pump, particularly for patients in whom delayed / discontinued therapy can lead to serious injury or serious adverse events. 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.