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Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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[Archived] Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contains a broken…
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Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda - MDA/2015/036
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Suspension due to particles found on some devices (MDA/2015/034)
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(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)
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[Archived] (Smith & Nephew Orthopaedics) Birmingham Hipâ„¢ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)
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(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…
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(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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(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)
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(All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)
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(All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)
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(Hospira) Due to pump faults. (MDA/2013/016)
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(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)
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
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[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)
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(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)
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(Covidien) reports of serious injuries after use of Stapler Duet TRSâ„¢ loading units in the thoracic cavity.(MDA/2012/005)
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(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)
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(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/2011/…
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
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(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)
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(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)
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(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)
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(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)
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(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)