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.

• Use of the affected product may result in free flow and / or overgrowth of medication, which may lead to adverse events for the patient. It is important for the customer to inspect the equipment before using a cassette by following the instructions below: • Release the cassette compartment by pressing the door latch and fully open the door. • Inspect the door roller visually for evidence of damage or misalignment. • Ensure that the door roller rotates easily when touched with your finger. If the door roller is loose, broken or not found, the infusion pump must be taken out of service and not used until the roller is replaced and / or the door is reassembled. Hospira informs that it has not yet received any reports of an adverse event related to the failure of the door locking roller in Brazil. Additional information or support regarding this issue can be obtained from Tel .: 0800 7733133 or (011) 5508.3100 Extension 3130. Email: tecnovigilância & pharmacovigilancia; @ hospira.com. Access security letter to the clients in: http://portal.anvisa.gov.br/wps/wcm/connect/21c5d3804e4a1a39b4bbb7c09d49251b/Carta_aos_clientes.pdf?MOD=AJPERES UPDATE: 12/01/2014 - until the present moment, it has been fulfilling in a satisfactory way the field actions related to the mentioned product, as proposed in 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).