Maquet cardiopulmonary requested the product back for investigation but product was not available.Furthermore product data regarding the involved set has been requested but none could be provided by customer.Only the data of the involved oxygenator has been submitted to manufacturer.A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.Based on this a confirmation of the failure is not possible.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is an systematic error.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-i which is registered under 510(k): k082117.
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