Model Number 106525 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 2 years 2 months 14 days.The patient remains ongoing with the lvad device.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 implanted with left a ventricular assistance device (lvad) on (b)(6) 2017.It was reported that the patient was seen in the emergency department noted power driveline fault alarm.The patient performed a controller switch to his back up controller without resolution of his alarms.He then proceeded to perform another controller switch back to his original primary controller without resolution.The driveline modular cable and system controller were exchanged with noted resolution of alarms.Patient was discharged (b)(6) 2019.Patient called back and stated he was in the car and didn¿t feel well and checked his controller and could not see any of his parameters except for the power.No audible alarms.The pump run symbol was illuminated.They were advised to return to the vad clinic.In the vad clinic, an lvad fault alarm was observed and they were unable to observe the vad parameters except for the power consumption.The file did capture false pump stop indications due to an issue with the pump current sensing feature.(this feature is not vital to pump operation.) this is the source of the lvad fault alarm the patient reported.While the flow value was not available the log file has a per second flow value available.It is graphed below along with pump power and pump speed.There was no interruption in pump support to the patient in this log file.No additional information was reported.
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Event Description
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It was reported that the patient has been well controlled since restarting lisinopril and increasing coreg, no vad communication issues, vad flows stable, and no hazard alarms overnight.Patient was discharged (b)(6) 2019.No additional information was reported.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the returned modular cable was in used condition.Visual inspection revealed that both bend reliefs were discolored and there was one burned pin inside the driveline connector.The returned modular cable was connected to the returned system controllers, a test pump, pm patient cable, power module, and system monitor.The system operated as intended without any alarms active; manipulating the cable had no effect on pump function and did not result in any alarm.The modular cable was functionally tested and passed the test procedure.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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