Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer:maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).Product was needed for investigation in the laboratory of manufacturer.It was requested on 2018-10-30 and received on 2018-11-23.However declaration of infection risk form was not received.It was requested respectively on 2018-11-23, 2018-11-28, 2018-12-05.No doir was received.Since the package of the product cannot be opened and investigated, the confirmation of this complaint is not possible.The contribution of product to the failure could not be identified.Also the serial number on the oxygenator cannot be read since it cannot be opened.Therefore no meaningful dhr review could be performed.Sap trend search was performed (product group 31000 & 56000, failure code 0306 oxygenation) which came to following results:12 additional complaints were recorded which appears reported issues are the same since the last 12 months.However 10 complaints are in status of 'not confirmed'.Based on the sales figures of the last 12 months following occurrence rate has been calculated: (b)(4), which is below than (b)(4).Due to this information no systemic issue could be determined.This complaint now will be closed.If any information becomes available which helps to determine the root cause, it will be reopened.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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