Alerts, recalls and safety information: drugs and medical devices

(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)

• Alert type: Device safety information
• Medical specialism: Critical care and 4 others
• Issued: 6 July 2015

[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)

• Alert type: Device safety information
• Medical specialism: General practice and 7 others
• Issued: 25 June 2015

(All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Possible cause may be Mycobacterium-contaminated water…

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 4 others
• Issued: 11 June 2015

(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 21 others
• Issued: 26 September 2014

(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 2 others
• Issued: 4 June 2014

(Waldemar Link GmbH & Company.KG) Consider annual review of patients for up to 5 years after implantation, including X-rays to detect progression of bearing wear. (MDA/2014/018)

• Alert type: Device safety information
• Medical specialism: Theatre practitioners
• Issued: 28 May 2014

(All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)

• Alert type: Device safety information
• Medical specialism: Cosmetic surgery and 2 others
• Issued: 24 January 2014

(Hospira) Use an alternative pump, where available. (MDA/2013/078)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 12 others
• Issued: 4 November 2013

(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 1 others
• Issued: 19 June 2013

(All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)

• Alert type: Device safety information
• Medical specialism: Critical care and 5 others
• Issued: 27 March 2013

(Hospira) Due to pump faults. (MDA/2013/016)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 14 others
• Issued: 26 March 2013

(Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (MDA/2013/006)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 4 others
• Issued: 20 February 2013

(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 6 others
• Issued: 11 September 2012

(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 9 others
• Issued: 28 June 2012

[Archived] (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)

• Alert type: Device safety information
• Medical specialism: Orthopaedics and 4 others
• Issued: 25 June 2012

(All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)

• Alert type: Device safety information
• Medical specialism: Care home staff and 4 others
• Issued: 12 April 2012

(Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.(MDA/2012/005)

• Alert type: Device safety information
• Medical specialism: Theatre practitioners and 1 others
• Issued: 16 February 2012

(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 2 others
• Issued: 1 December 2011

(All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/…

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 5 others
• Issued: 15 June 2011

(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)

• Alert type: Device safety information
• Medical specialism: Anaesthetics and 3 others
• Issued: 8 June 2011

(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)

• Alert type: Device safety information
• Medical specialism: General surgery and 3 others
• Issued: 15 March 2011

(All) harm of inadequate patient ventilation and oxygenation could have been avoided if an alternative means of ventilation had been used earlier. (MDA/2010/036)

• Alert type: Device safety information
• Medical specialism: General surgery and 1 others
• Issued: 6 May 2010

(All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used. (MDA/2010/002)

• Alert type: Device safety information
• Medical specialism: Care home staff and 2 others
• Issued: 5 January 2010

(All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)

• Alert type: Device safety information
• Medical specialism: Cardiology and 2 others
• Issued: 22 September 2008

(St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)

• Alert type: Device safety information
• Medical specialism: Critical care and 3 others
• Issued: 25 July 2005