Alerta De Seguridad O Notificaciones De Seguridad para Suction canisters and liners, Receptal system

Safety alert / Field Safety Notice

MDA/2013/026

CON270677

2013-05-01

2013-05-01

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON270677?tabName=allTabs

Potential failure or loss of suction. due to a number of customer complaints, hospira has issued a field safety notice (dated 12 april 2013) to recall all 1 litre devices and instruct customers to seek alternatives. the mhra is not confident that hospira has sufficient alternative stock available to supply the demand during a recall. the vacuum needed to create the suction cannot be created if the hard canister and the single-use liner are not properly seated during use, or if the liner separates from the canister during use. hospira has not yet identified the root cause of this failure. an investigation is ongoing. hospira cannot guarantee that the pre-use checks (listed below) will identify all defective units. therefore, a unit could pass the pre-use checks and still fail during use.

Identify affected devices. Ensure that users are aware of the manufacturer’s Field Safety Notice. Seek alternative devices immediately and return affected devices to the manufacturer. Until alternative devices are available: Perform pre-use checks (see below).  If defective units are identified, remove from use. Exercise caution in use as failure can occur despite the pre-use checks. Ensure that a back-up suction device is available at all times. Until alternatives are made available, the following pre-use checks should be carried out: During assembly, check the underside of the liner lid to ensure that the liner is not misaligned and there is a flush connection. Verify that the correct vacuum pressure can be achieved and that there is no loss of suction.