Additional information added to h6 and h10.H10: the device was not received for evaluation; however, the machine was evaluated by an on-site technician.The technician noted alarms were stacked and included bag empty, access disconnection, effluent line clamped, heparin syringe empty.The customer attempted to reinstall the same syringe and the syringe arm did not stop at the plunger and delivered the contents of the syringe into the circuit.The syringe line should have been clamped during changing syringe.This alarm is unlikely to occur in case the syringe piston is locked as prescribed.However, the biomed didn¿t report any defect or anomaly of the machine was found during the evaluation.Per the operator manual, on "anticoagulation" chapter, "for systemic anticoagulation, to infuse anticoagulant between the blood pump and the filter, connect the syringe to the syringe line on the disposable set.Stow the syringe line on the disposable set along the left side of the set cartridge.Clamp the syringe line when changing the syringe.When the syringe is installed, follow the onscreen instructions to unclamp the syringe line.The syringe flow cannot be changed during a syringe change".The reported condition was verified.The cause of the condition was due to a user error.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
|