The managing director of maquet cardiopulmonary forwarded the letter from a relative of the patient to maquet cardiopulmonary gmbh, dcu on 2020-01-20.All complaints since 2014 were reviewed on 2020-01-21, but no complaint was found that could be related to the reported event.Therefore complaint no (b)(4) was created after consultation with the director of regulatory affairs on 2020-01-23.In order to fulfil possible reporting obligations, this event was reported on: 2020-01-28 initial mir to united kingdom , 2020-02-11 initial emdr , 2020- 02-12 initial report to row , 2020-03-27 follow up 1 mir to united kingdom.On 2020-02-26 mcp sent a letter to the relatives of the patient to inform them about the ongoing complaint investigation.A request for clarification of the complaint report was sent to the customer on 2020-03-10 (reference no foi request (b)(4)).The freedom of information (foi) department from the south tees hospital nhs foundation trust has responded to the foi request (b)(4) on 2020-04-27.During the investigation it was confirmed that the hospital does not use any maquet cardiopulmonary (mcp) devices.Therefore maquet cardiopulmonary gmbh is not the legal manufacturer of the product in question and this is not a customer product complaint by definition (reference to (b)(4) customer product complaint handling process).
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