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.

The root cause of the problem is the undersized diaphragm (out of specification) manufactured by the component supplier. Both N250 and N100 events emit a visual and audible alarm to the user, which may occur during programming, use or performance testing (PVT) of the pump. Error codes N250 or N100 may cause delay or interruption of the infusion. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. 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 use of an alternative pump, particularly for patients in whom delayed / discontinued therapy can lead to serious injury or serious adverse events. If any of these alarms appear, remove the cassette and reload it into the pump as described in the pump operation manual. If the recharge of the cassette fails to clear the alarm, replace the cassette and restart therapy. If the error persists, the pump has the diaphragm out of specification. Remove the pump from use and contact Hospira to report the event and schedule a review and repair (if necessary) of the pump. Access to the letter, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/89317a804f861883b3d1f79a71dcc661/1+-+FA212-04_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). #### 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. #### UPDATED ON 08/23/2017, the field action documents sent by the company are filed in the area. If necessary, the area can reassess the action at any time.