Model Number 397002-001 |
Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited diastolic waveform delay with decreased cardiac output, it continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4) initial.
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Event Description
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The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited diastolic waveform delay with decreased cardiac output while supporting a patient.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The customer-reported increased systolic duration was reproduced during investigation testing, where the time in systole (pressure waveform) increased and the flow waveforms displayed a timing delay (decreased time in diastole).The root cause of the customer-reported issue was determined to be a malfunction of the left and right pilot valves, which causes a delay in the start of diastole, elongating the time in systole.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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