The complained products were requested for the sample investigation.Two oxygenators (hqv 0737 # hlm - set mod.Tübingen cormed) were delivered as complaint samples.The oxygenators were cleaned with sodium hypochlorite and disinfected with incidin liquid.Visual inspection and a leak test according to local procedure lv 201 (blood side) were performed.During the leak test, a leak was found at the tube connections of the both oxygenator.The damages a the tube connection is not related to the definiton of the problem.No pressure abnormalities were found in the function test using a roller pump.Trend search was performed and no systemic issue could be found.Device history record review for complaint (b)(4) and lot 70129356 was performed.There were no references found which are indicating a nonconformance of the product in question.The device was manufactured in compliance with defined production steps and specifications.Appropriate manufacturing documentation and production step controls were in place.Therefore no manufacturing problem was detected.The reported failure was identified as part of the current risk management file (dms #1464420 v15)mitigations for this specific failure are in place as per design specifications and in instruction for use.Mitigation-112/ instruction for use: a pressure drop on the oxygenator can be a sign of reduced performance.This can lead to inadequate patient support.Monitor the pressure drop by measuring the pressure upstream and downstream of the oxygenator.Consider replacing the oxygenator if the pressure drop is significant.Check the gas exchange rate using blood gas analyses.Prepare to replace the oxygenator.Mitigation-061/ design.The surfaces of the quadrox-i-id small adult / adult with blood contact shall consist of hemocompatible material according to din en iso 10993-4.Maquet cardiopulmonary gmbh is aware of similar failure from this product and same customer.Same product, showing a similar malfunction, has been investigated in detail in #266181.As a result of the investigation, no evidence was found that the failure was related to the product.Thus, no remedial action is required.The failure could be confirmed.However, the exact cause of the failure could not be identified.The reported failure did not contribute to death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.Thus, no remedial action is required.No corrective actions are required.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.
|