The customer reported to physio-control that cpr was provided by a lucas 2 chest compression system (device) to a patient being treated for cardiorespiratory arrest.It was reported that, following the use of the device, the patient developed some rib fractures and a hepatic laceration that required an embolization.The patient was later transferred to another hospital and developed a sepsis on a superinfected hepatic hematoma that required bi-segmental hepatic resection.The patient's outcome was not reported.The customer reported that the use of the device may have caused or contributed to the hepatic laceration which required embolization by surgical intervention.
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The customer reported to physio-control that the patient survived the reported event.The customer also reported to physio-control that the device was being used to administer chest compressions for 20 minutes.Additionally, they indicated that they were unaware if the device stabilization strap was used during the event.Based on the available information, there is no clear indication of a device malfunction or a use error associated with the reported event.A clinical review of the reported issue was performed by (b)(4) and physio-control with the following feedback/conclusions: complications involving the liver are known to occur with manual cpr as well as mechanical cpr.In this case it is unclear if the suction cup was placed correctly.Therefore, it is difficult to determine if the injury was caused by correct manual or mechanical cpr or by a misplacement of the device on the patient.However, with the information provided it is possible that lucas compressions contributed to the reported liver laceration.As described in the scientific literature, the risk of complications from cpr never outweighs the benefit of return of spontaneous circulation.Knowing the risks is important for treatment issues after rosc, because both manual and mechanical cpr may lead to injuries.Platenkamp et al, complications of mechanical chest compression devices.Neth heart j.2014 sep; 22(9): 404¿407.
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