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List of Field Safety Notices from15 to 19 April 2024.
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(Lundbeck Limited) May result in suboptimal dosage of the product - class 2 action within 48 hours. (EL (14)A/19)
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.
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(Hospira) Due to pump faults. (MDA/2013/016)
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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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BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.
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(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)
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Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
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CME has recommended the need for protection of these pumps when exposed to direct sunlight.
In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with the T34 pumps (MDA/2016/002)…
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List of Field Safety Notices (FSNs) from 15 to 19 January 2024.
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Summary list of field safety notices (FSNs) from medical device manufacturers from 6 to 9 April 2020
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(All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. (MDA/2008/038)
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Following our latest review of medical device alerts, we have archived the ones listed below.
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 2015.
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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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List of Field Safety Notices (FSNs) from 21 to 25 August 2023.
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Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
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List of Field Safety Notices (FSNs) from 6 to 10 February 2023.
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List of Field Safety Notices (FSNs) from 28 August to 1 September 2023.
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List of Field Safety Notices from 1 to 5 April 2024
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Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 2022
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Summary list of field safety notices (FSNs) from medical device manufacturers from 06 July to 10 July 2020
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 January 2019
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List of Field Safety Notices (FSNs) from 14 to 18 August 2023.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 August 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 11 April to 15 April 2016
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List of Field Safety Notices from 25 to 29 March 2024.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 June 2021.
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List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2021
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 September 2016
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List of Field Safety Notices from 13 to 17 November 2023.
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The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.
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List of field safety notices (FSNs) from medical device manufacturers from 4 January to 8 January 2016.
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List of Field Safety Notices (FSNs) from 14 to 18 November 2022
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Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021
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(Edwards Lifesciences Ltd) the manufacturer has updated their corrective actions for software problems with haemofiltration machines. (MDA/2009/076)
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List of field safety notices (FSNs) from medical device manufacturers from 27 to 31 July 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 May 2015.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 19 - 23 December 2016
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021
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List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 November 2021
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List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 March 2021
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List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 July 2019
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Field Safety Notices from 27 November to 1 December 2023
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List of Field Safety Notices from 18 to 22 December 2023
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List of Field Safety Notices from 30 October to 3 November 2023.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 April 2017