It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the calcium pump stopped without triggering an alarm.The patient did not receive the calcium infusion for 10 hours.Once the issue was noted, the operator ¿gently touched¿ the syringe pump and an error message was triggered.The extracorporeal blood was not returned to the patient.Treatment was discontinued.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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A sample was not received for evaluation.The event history log was analyzed and it was noted that during treatment a syringe change procedure was performed.Six hours later, another syringe change procedure was performed.This was followed by a malfunction alarm ¿ general system failure (code 6) and malfunction alarm ¿ syringe pump (code 9),and treatment was stopped.The analysis revealed that no calcium was delivered between the change syringe procedures.Ten three hour long simulated treatments with rca anticoagulation and a syringe change within ten minutes of the first self-test were performed on a control unit in the baxter workshop, and no issues were observed during therapy.The reported condition was verified.The cause of the condition was not determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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