An area technical operations manager (atom) for a user facility reported that the fresenius 2008t hemodialysis (hd) machine was giving arterial pressure, venous pressure, and transmembrane pressure (tmp) alarms during patient treatment.The arterial drip chamber would run low or out of blood and the venous chamber would overfill and wet the venous transducer.The patient¿s blood clotted in the venous chamber, resulting in blood loss.There was no patient injury or adverse reaction reported.The patient¿s blood was returned and the staff changed the venous line and the patient completed treatment.The dialyzer is primed at 150ml/min.The machine is set-up with bloodlines and the venous chamber is primed.The arterial and venous transducer lines are clamped and hung from the pressure ports with the transducers attached.The machine self-test runs and when the patient arrives, the arterial and venous transducer lines are attached to the pressure ports and the hansen lines are connected to the dialyzer where the priming is completed.The dialyzer is inverted during the priming of the circuit.Following the event, the machine was removed from service for evaluation.The atom has troubleshooted the machine but has not identified the source of the issue.A fresenius regional equipment specialist (res) performed on-site service on 11/3/17.The res verified tmp pressure and advised the atom to change the diasafe plus filter and to try another lot of blood lines.The machine functioned as intended.The atom stated that the machine reportedly continued to have the issue.The res was on-site again on 11/16/17.The res could not duplicate the issue.All functional checks passed.No repairs were made by the res.The machine is currently in use at the user facility.No parts are reported to be available to be returned to the manufacturer for evaluation.No further information has been made available at this time.
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No parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) on (b)(6) 2017.The res verified tmp pressure and advised the atom to change the diasafe plus filter and to try another lot of blood lines.The machine functioned as intended.The res was on-site again on (b)(6) 2017.The res could not duplicate the issue.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to confirm the failure mode.The res verified that the machine was operating properly.Therefore, the complaint has been deemed unconfirmed.
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