Events

Safety Alert for Lifecare Plum A + Infusion Pump - ANVISA Registration #: 80253310023,

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Hospira Costa Rica Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1225
  • Date
    2012-11-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    • 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).
  • Reason
    It has been identified in some plum a + infusion pumps that improper handling of the equipment may cause rupture of the cassette attachment roller located in the door assembly, which may result in free flowing and / or overdose of medication, which may adverse events to the patient.
  • Action
    Hospira Produtos Hospitalares Ltda. Is sending customers a statement recommending inspection of the settling roller and will redesign the roller to improve strength and reduce ruptures.

Device

Lifecare Plum A + Infusion Pump - ANVISA Registration #: 80253310023,

Manufacturer

Hospira Costa Rica Ltd.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    ANVSANVISA