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 broken sensor pin may result in incorrect distal pressure readings, inadvertent distal occlusion, and / or unidentified tape failure. Hospira's investigation concluded that the root cause of the damaged distal pressure sensor pin is improper placement of the cassette into the pump and then closure of the door. Thus, to prevent this occurrence, it is important to place the cassette into the pump according to the instructions described in the pump operating manual. These situations can lead to delayed or interrupted therapy, overdose or lower dose than desired, which in the worst case can cause a serious injury or cause 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 contact a Hospira representative for the use of an alternative pump, particularly for patients in whom delay / discontinuation of therapy may result in serious injury or serious adverse events. Hospira recommends that health services immediately perform visual inspection on their Plum A + infusion pumps to verify that the distal pressure sensor pin is broken or damaged. The steps for performing visual inspection of the distal pressure sensor pin are as follows: • Release the cassette door: open the lever, push the release latch, and fully open the door. • Visually inspect the distal pressure pin for any signs of damage. See photo (attached). If the distal pressure pin is broken, withdraw the pump from use and contact Hospira to report the problem. Access to the letter, see the link: http: //portal.anvisa.gov.br/wps/wcm/connect/14b316004f86192db3daf79a71dcc661/3+-+FA212-08_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.