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25 Aug 2016

CLH Blog - MHRA updates for August

CLH Blog - MHRA updates for August

Welcome to our fifth monthly medical field safety alerts blog, this time for the month of August. Once again we will be detailing healthcare product updates and alterations that are relevant for UK care homes and listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers.

August’s alerts:

  • Corinthian Surgical Ltd: SerenoCem Granules – Product Recall
    Corinthian Surgical Ltd has issued a product safety alert for its SerenoCem Granules that are used in ear surgery. There is a risk of bone reabsorption around the implanted granules, and therefore any unused units of SerenoCem Granules should be returned to Corinthian Surgical Ltd without use.
    For more information about this alert and what action to take, please see here.

  • Nipro Diagnostics: TRUEresult & TRUEtrack Blood Glucose Test Strips – Recall/Safety Alert
    Diagnostics has noticed that certain lots of the above-mentioned test strips may give incorrect low blood glucose results that could lead to hyperglycaemia. Patients are advised to discontinue use of these batches, and return any used units to Nipro Diagnostics.

  • Roche Diabetes Care: Accu-Check® Insight Insulin Pump System – Product Instruction
    Roche Diabetes Care has become aware that incorrectly inserted cartridges can leak insulin into the cartridge compartment, resulting in an under-delivery of insulin. This has several negative knock-on effects, so further training is needed for staff to ensure this does not keep occurring.

    For more information about this alert and what action to take, please see here.

  • Nutricia: Flocare Infinity Enteral Feeding Pump – Incident Alert
    Nutricia has received reports that the Flocare Infinity Enteral Feeding Pump ‘Air in Line’ alarm functionality may not always work with mixed or reconstituted powdered nutrition. This poses a hazard to patients, but there is yet to be an incident of this in the UK – so please inform your resident at your own discretion.

    For more information about this alert and what action to take, please see here.

  • ResMed: Astral 100/150 Internal Battery – Field Safety Alert
    ResMed has become aware that some of the internal batteries used in its Astral 100/150 products have been found to have poor performance. This has the potential to put a patient in danger if the battery dies without sounding its ‘low battery’ alarm, leading to a patient’s ventilation ceasing without warning.

    For more information about this alert and what action to take, please see here.

  • Boehringer Ingelheim Limited: Actilyse 20mg and 50mg – Field Safety Alert
    Boehringer Ingelheim Limited has reported incidents of the rubber stopper being pushed into the vial during reconstitution – rendering the vial unusable.

    For more information about this alert and what action to take, please see here.

    Please note this is not a definitive list of field safety alerts, please visit the MHRA website for more.

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