tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices for National patient safety alert2024-04-04T12:38:20+01:00HM Governmenttag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-reducing-risks-for-transfusion-associated-circulatory-overload-natpsa-slash-2024-slash-004-slash-mhra2024-04-04T12:38:20+01:00National Patient Safety Alert: Reducing risks for transfusion-associated circulatory overload (NatPSA/2024/004/MHRA)TACO is one of the most common causes of transfusion-related deaths in the UK and cases have increased substantially in recent years. Identifying risk factors for TACO prior to transfusion allows initiation of appropriate mi…tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-valproate-organisations-to-prepare-for-new-regulatory-measures-for-oversight-of-prescribing-to-new-patients-and-existing-female-patients-natpsa-slash-2023-slash-013-slash-mhra2023-11-28T16:31:49+00:00National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA)The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advic…tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-medical-beds-trolleys-bed-rails-bed-grab-handles-and-lateral-turning-devices-risk-of-death-from-entrapment-or-falls-natpsa-slash-2023-slash-010-slash-mhra2023-08-30T14:30:55+01:00National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA)The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-potential-risk-of-underdosing-with-calcium-gluconate-in-severe-hyperkalaemia-natpsa-slash-2023-slash-007-slash-mhra2023-06-27T12:32:25+01:00National Patient Safety Alert: Potential risk of underdosing with calcium gluconate in severe hyperkalaemia (NatPSA/2023/007/MHRA)This alert highlights the Adult Renal Association Clinical Practice Guidelines (2020) recommendation on calcium gluconate use to support organisations to update local policies and guidelines for the treatment of severe hyper…tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-removal-of-philips-health-systems-v60-and-v60-plus-ventilators-from-service-risk-of-shutdown-leading-to-complete-loss-of-ventilation-natpsa-slash-2023-slash-005-slash-mhra2023-05-18T10:59:47+01:00National Patient Safety Alert: Removal of Philips Health Systems V60 and V60 Plus ventilators from service: risk of shutdown leading to complete loss of ventilation (NatPSA/2023/005/MHRA)The MHRA is issuing updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use.tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-emerade-500-micrograms-and-emerade-300-micrograms-auto-injectors-due-to-the-potential-for-device-failure-natpsa-slash-2023-slash-004-slash-mhra2023-05-09T12:30:14+01:00National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRAPharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-nidek-eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-risk-of-increased-intraocular-pressure-natpsa-slash-2023-slash-003-slash-mhra2023-02-01T15:29:50+00:00National Patient Safety Alert: NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure (NatPSA/2023/003/MHRA)The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distribute…tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-targocid-200mg-powder-for-solution-for-injection-slash-infusion-or-oral-solution-aventis-pharma-limited-t-slash-a-sanofi-due-to-the-presence-of-bacteria2022-10-21T11:00:35+01:00National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRASanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solutiontag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-mexiletine-hydrochloride-50mg-100mg-and-200-mg-hard-capsules-clinigen-healthcare-ltd-due-to-a-potential-for-underdosing-and-slash-or-overdosing-natpsa-s2022-08-04T14:28:26+01:00National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Mexiletine hydrochloride 50mg, 100mg and 200 mg Hard Capsules, Clinigen Healthcare Ltd, due to a potential for underdosing and/or overdosing, NatPSA/2022/007/MHRAClinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-philips-health-systems-v60-v60-plus-and-v680-ventilators-potential-unexpected-shutdown-leading-to-complete-loss-of-ventilation-natpsa-slash-2022-slash-002-slash-mhra2022-07-29T15:48:20+01:00National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)Philips Health Systems have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care settings …tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-novorapid-pumpcart-in-the-roche-accu-chek-insight-insulin-pump-risk-of-insulin-leakage-causing-hyperglycaemia-and-diabetic-ketoacidosis-natpsa-slash-2022-slash-004-slash-mhra2022-05-26T12:49:17+01:00National Patient Safety Alert: NovoRapid PumpCart in the Roche Accu-Chek Insight insulin pump: risk of insulin leakage causing hyperglycaemia and diabetic ketoacidosis (NatPSA/2022/004/MHRA)The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequ…tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-philips-ventilator-cpap-and-bipap-devices-potential-for-patient-harm-due-to-inhalation-of-particles-and-volatile-organic-compounds-natpsa-slash-2021-slash-005-slash-mhra2021-06-23T15:51:45+01:00National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds (NatPSA/2021/005/MHRA)Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices.tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-co-codamol-30-slash-500-effervescent-tablets-batch-1k10121-zentiva-pharma-uk-ltd-due-to-precautionary-risk-of-causing-overdose-natpsa-slash-2021-slash-02021-06-16T11:00:08+01:00National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Co-codamol 30/500 Effervescent Tablets, Batch 1K10121, Zentiva Pharma UK Ltd, due to precautionary risk of causing overdose, NatPSA/2021/004/MHRAZentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for …tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-supply-disruption-of-sterile-infusion-sets-and-connectors-manufactured-by-becton-dickinson-bd-natpsa-slash-2021-slash-001-slash-mhra2021-03-11T16:33:47+00:00National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)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. tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-philips-respironics-v60-ventilator-unexpected-shutdown-natpsa-2020-007-mhra2020-09-23T15:27:23+01:00National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA) Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation