It was reported that within 30 minutes of restarting continuous renal replacement therapy with a new prismaflex control unit, a pediatric patient experienced bronchospasm, hypotension and tachycardia in the 160s.The pre blood pump prescription was increased and the patient was given a fluid bolus and two doses of calcium.The patient's condition stabilized.Shortly afterwards, "the patient was at full flows on the circuit per prescription" and the patient began to show clinical signs of change.Approximately twenty minutes later, the machine alarmed with return disconnection and filter clotting.At this time, the patient started seizing, experienced bradycardia, and became hypotensive.At this time, the patient's pupils were observed to be fixed and no pulse was palpable.Treatment was terminated and blood was not returned to the patient.Amount of blood loss was not reported.Cardiopulmonary resuscitation was performed for 45 minutes before the patient stabilized and was placed on extracorporeal membrane oxygenation.No additional information is available.
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B6: patient's at time of treatment was 130/70.H10: the device was received for evaluation.A device history review of complaints and service reports of the last 24 months revealed that the device had previous reported events of self-test failure alarm (code 4).The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.There was no malfunction observed on the device.The cause of the reported condition could not be determined.The should additional relevant information become available, a supplemental report will be submitted.
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