Incidents and alerts
Report an incident via the NPSA website: www.nrls.npsa.nhs.uk/report-a-patient-safety-incident
Please click on the buttons below to view the latest alerts.
MHRA
 MHRA Medical Device Alert
Processing AT1 set (item no. 9005101) used with the CATS® continuous autotransfusion system. Sets manufactured between January 2009 and April 2010 are affected - 26 August 2010
Manufactured by Fresenius Kabi Ltd & Calea UK Ltd
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON090761
MHRA Medical Device Alert
Various models of Anaesthetic CareStations - 6 August 2010
Manufacturer: GE Healthcare
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON087755
MHRA Medical Device Alert
Welch Allyn CP200 Electrocardiograph - 30 July 2010
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON085087
MHRA Medical Device Alert
Trusat Pulse Oximeter. Part numbers 605100000-190, 60510000-191, 60510000-192, 60510000-193 2010 - 28 July 2010
Manufacturer: GE Healthcare
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON085082
MHRA Medical Device Alert
Unilect ECG monitoring electrodes manufactured by Unomedical (a ConvaTec Company) - 23 June 2010
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON084595
MHRA Medical Device Alert
Visionary single-use laryngeal airway device (LAD) manufactured by Marshall Products Ltd - 2 June 2010
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON081919
MHRA Medical Device Alert
Aquarius Haemofiltration Machines - 12 May 2010
All Aquarius Haemofiltration Machines.Manufacturered by Edwards Lifesciences ltd and supplied by Baxter Healthcare.
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON081883
MHRA Medical Device Alert
The MHRA has announced a recall alert for several thousand Larnygeal Masks manufactured by Marshall Products Ltd
Please click here to download a pdf of the alert.
MHRA Medical Device Alert
Shiley cuffed tracheostomy tubes (Covidien) – 20th April 2010
Shiley cuffed tracheostomy tubes. Specific lot numbers manufacturer: Coviden (formally Tyco Healthcare).
The Alert may be found at:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079105
MHRA Medical Device Alert
Alaris volumetric pumps – 27 April 2010
Alaris GP and Alaris GP Guardrails Volumetric Pump with plus software. Models 9002MED01 and 9002MED01-G. Software Version 2.1.12.
The Alert may be found at: http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079220
MHRA Medical Device Alert
The MHRA have issued a Medical Device Alert emphasising the importance of the early use of a self-inflating bag to assist in the diagnosis and treatment of difficulty with ventilation. The AAGBI has been closely involved in the preparation of the Alert and strongly endorses it. The Alert may be found at http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON081785.
MHRA Medical Device Alert
The Medicines and Healthcare Products Regulatory Authority Agency (MHRA) has issused a Medical Device Alert about Anaesthetic Gas Scavenging (AGSS). This has arisen in part because of concerns raised by MHRA, AAGBI and BAREMA (the British Anaesthetic & Respiratory Equipment Manufacturers Association) about changes to the International Standard (ISO). The ISO will be reviewed later this year, and AAGBI will be contributing to this.
The Alert can be found at http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON076104?tabName=Device
Please ensure that AGSS systems in use in your hospital do not pose a patient safety risk.
MHRA Medical Device Alert
The MHRA has issued a Medical Device Alert about the TEC6 Plus Desflurane Vapouriser, manufactured by GE Healthcare. An unexpected age related failure may result in over or under delivery of anaesthetic agent, and in some cases this may have been interpreted by anaesthetists as a monitoring failure rather than a problem with agent delivery. More details can be found at: http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON062635.
Andrew Hartle
Chairman, AAGBI Safety Committee
NPSA
The NPSA issued a Rapid Response Report on 26 August 2010 regarding the prevention of over infusion of intavenous fluid and medicines in neonates. There is a risk of the accidental over infusion of intravenous fluid* and medicines to neonates associated with the setting up of specific intravenous infusions or the overriding of safety mechanisms on infusion pumps.
*This action does not apply to the administration of blood components to neonates. These should continue to be administered as per The British Committee for Standards in Haematology ‘Guidelines on the Administration of Blood Components' (2009) www.bcshguidelines.org/pdf/Admin_blood_components050110.pdf (pg.51)
Further details may be found on the NPSA website:
http://www.nrls.npsa.nhs.uk/alerts/?entryid45=75519
The NPSA issued a safety Signal in November about the hazards, especially to children, of residual anaesthetic drugs in cannulae. Several incidents have occurred when residual muscle relaxant may have led to sudden collapse.
It would appear that many anaesthetists may not have seen this, and AAGBI Council wishes to bring this hazard to your attention.
Further details may be found on the NPSA website: http://www.nrls.npsa.nhs.uk/resources/type/signals/?entryid45=65333&p=2
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