Model Number 201-90010 |
Device Problems
Air Leak (1008); Noise, Audible (3273)
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Patient Problem
Air Embolism (1697)
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Event Date 05/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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The patient's age, gender and weight were not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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The patient was placed on biventricular extracorporeal circulatory support.It was reported that 7 days after implant on (b)(6) 2018, low flow alarms occurred and air bubbles were observed during echocardiography of the right ventricle.The patient also developed dark urine.Noise from the pump was heard.A decision was made to stop the pump and exchange the motor.Patient support and pump flow resumed back to normal.The patient's urine went back to normal.No additional information was provided.
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Manufacturer Narrative
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The lot number of the device was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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Additional information: clarification was provided indicating that the healthcare professionals believed the issue was the motor as the pump head was not exchanged.They only changed the motor with the same pump head.No additional information was provided.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the device was not returned for evaluation.A correlation between the reported event and the blood pump could not conclusively be determined through this evaluation.Additionally, a root cause for the event could not conclusively be determined.The centrimag blood pump instructions for use (ifu) states to monitor the arterial line for air because the centrimag blood pump, similar to other centrifugal pumps, will pump air.Stop infusion if air enters the pump as gaseous emboli may be introduced into the patient.It also states to determine the proper position for the pump in the extracorporeal circuit.It also states to always have a spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.
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Manufacturer Narrative
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Section d3: correction.
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Search Alerts/Recalls
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