BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955558 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported during continuous renal replacement therapy (crrt) with a prismax control unit and a prismaflex set, a patient experienced several clotting incidents over the span of five days despite using different types of anticoagulants.Extracorporeal blood was not returned to the patient.Blood loss was approximately 800 ml.No patient symptom was reported, however, the patient received blood two blood transfusions on the sixth day and one blood transfusion two days later.Negative access alarms were generated around 20-30 times in 24 hours.No additional information is available.
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Manufacturer Narrative
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H10: the device was not received for evaluation.A device history review revealed no issues that could have caused or contributed to the reported issue.The log file records reviewed only one of the treatment lasting 15 hours.An alarm t1298 syringe_force_low was triggered as a negative pressure of the return access and was transmitted to the filter pressure.This caused an uncontrolled suction of the anticoagulant fluid in the extracorporeal circuit.The cause of the heparin bolus was the user didn¿t lock the heparin syringe piston as required by the prismax operator¿s manual.The analysis of the log file did not reveal any anomaly of the pressure measurement during and after the repositioning of the pod.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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