Maquet cardiopulmonary gmbh was not requested the product back for investigation since the issue is known.Maquet cardiopulmonary ag is aware of similar complaints from this product.Similar product, showing a similar malfunction, has been investigated in (b)(4).Under scope of the complaint (b)(4) ; maquet cardiopulmonary gmbh was received the product back for investigation.A quadrox-i was returned.The product was contaminated.Visual inspection was performed.A long crack on the luer lock near the vent cock was detected, so, it was decided that the leak test was not necessary.No other abnormalities could be detected.The failure was confirmed by the laboratory.The manufacturer`s review of the control form in production indicated that a 100% visual inspection is conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.
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