It was reported that the hls module was disconnected from the cardiohelp during patient treatment.No harm to any person reported.They changed the set out and tried to replicate the error with the old hls set using a second cardiohelp unit and could not replicate.The affected product was not available for further investigation as it was discarded by the customer without any notes of the lot number.No visible damage was noticed on the hls set or the cardiohelp, neither before nor after the event by the customer.Based on the given information, the cause of the event could not be attributed to the device.Thus the reported failure could not be confirmed.According to the hls risk assessment (dms#1468452, v26) the most probable root cause is that hls module was not securely fixated into the cardiohelp-i-drive.In the instruction for use ( hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v1.5, chapter 5.3.1 safety instructions for the oxygenator) is stated to ensure that the device is fitted onto the drive correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump.In order to avoid the reoccurrence of the reported event the ssu (sales and service unit) should inform the user about the investigation results and the above mentioned sections of the ifu.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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