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.

Although sensor drift is normal and expected throughout the use of the pump, Hospira has identified some design attributes that may indicate deviation occurring earlier than expected: moisture in the voltage gauge linings, structural stress of the sensor chassis, or relaxation of the clamping force of the set screws of the meter assembly and the pressure pin. When the calibration deviation of the distal pressure sensor occurs, the pump does not alarm when it exceeds the occlusion limit. Partial or total occlusion may prevent fluid from reaching the patient and may result in delay, interruption of therapy or reduced infusion, which in the worst case can cause serious injury or serious adverse events. If this results in late distal occlusion alarm, excessive fluid and pressure may gradually increase in the distal line without the sensor detecting the distal pressure. When the distal occlusion is resolved, the fluid gradually increases and may cause an overdose. Overdose may cause serious injury or serious adverse effects. 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/da18a0004f861963b3e3f79a71dcc661/4+-+FA212-09_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.