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The following was reported: "critically ill patient who was transferred directly from (b)(6) hospital after a rapid onset with the development of critical respiratory failure.She was placed on veno-venous ecmo and initially this circuit worked fine.As one of the patient's nurses adjusted the position of the venous tube and the air bubble sensor slightly, the alarm for air in the tube and the machine stopped.It was not possible to restart the machine until the perfusionist arrived after less than two minutes.The patient had then stopped circulating and could not be revived." maquet cardiopulmonary requested the hardware in question for further investigation.The device is not available for technical investigation.The hls set is not available for technical investigation.Log files analysis of the cardiohelp system was performed on 2020-11-17 by getinge life-cycle engineering.The log files shows that the device had no malfunction.According to the service protocol dated 2020-11-06 the device was checked by a getinge service technician during the preventive maintenance.The unit was tested as per factory specifications and passed all tests.The unit was put back in use.Furthermore a medical review was performed by getinge medical experts: after the assessment of all available data, it was identified that the used device (cardiohelp) functioned as designed.No causality between the patient¿s expiration and the device functionality could be found after reviewing the complaint and correspondence related to reported complaint.Furthermore in the general safety instructions (chapter 2.2.) of the ifu (instructions for use | 1.8 | en | 09) the following warnings are stated: the system must be operated by trained specialist medical staff.The system must be monitored and documented by a trained member of specialist medical staff.You should always keep a replacement unit on standby in order to ensure continuous operation in the event of a complete system failure.During clinical use of the cardiohelp-i, the medical personnel must always be able to resuscitate and intubate the patient.Furthermore in chapter 2.2.3 "handling the cardiohelp" a warning is included that the user must check the availability and function of the cardiohelp emergency drive prior to each application.Also with reference to the current instruction for use (instructions for use | 1.8 | en | 09) of the cardiohelp the following warning is stated in chapter 6 (during the application): "only operate the cardiohelp-i with activated pressure and temperature sensors.Ensure that the warning and alarm limits, as well as interventions, are suitable for the patient and current situation." the chapter 6.1.1 includes the following warning: "before beginning the application, ensure that the selected warning and alarm limits, as well as interventions, are suitable and safe for the patient and the current situation." the risk analysis v22 chapter 10.1.1 was reviewed and most possible root causes could be determined as follows: user not able to handle ch: inadequate knowledge of user, missing training, unknown alarms (text, sound), symbols not understandable / misleading, message not understandable / not known, manual not in needed language, unable to unlock device, incorrect language setting, user routine / handling violation, message not understandable / not known / cross references for more information not usable, training fails (inadequate training).Based on the above mentioned investigation results the reported failure "pumps stop" could be confirmed, but there is no relation to a product malfunction.Thus no product related malfunction lead to the patient's death.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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