Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2016 – 31.10.2016

Опубліковано 06.12.2016 о 00:00


·         Medical device alerts archived in October 2016

A list of all medical device alerts that were archived in October 2016.

Alert type: Medical device alert Issued: 27 October 2016

·         Total intravenous anaesthesia sets (TIVA) – risk of leakage during use

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)

Alert type: Medical device alert Medical specialism: Anaesthetics and 4 others Issued:  27 October 2016

·         Managing diabetes: patients should not change their insulin delivery device without checking with their healthcare specialist

If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypoglycaemia or diabetic ketoacidosis.

Alert type: Medical device alert Issued:

26 October 2016

·         Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) – risk of loss of therapy due to rapid battery depletion

Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.

Alert type: Medical device alert Issued: 17 October 2016

·         Automatic external defibrillator (AED) LIFEPAK CR Plus and LIFEPAK EXPRESS – risk of failure to deliver a shock.

Manufactured by Physio-Control – risk of delay to defibrillation due to an intermittent component failure.

Alert type: Medical device alert Issued: 13 October 2016


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