Catalog Number 397002-001 |
Device Problems
Filling Problem (1233); Low Readings (2460)
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Patient Problems
No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
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Event Date 06/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The customer, a syncardia authorized distributor, reported that the patient stated he didn't feel well and then the companion 2 driver experienced a fill volume drop to zero.The customer also reported that there was no clinical impact on the patient and the patient was subsequently switched to a backup driver without any reported adverse patient impact.
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Manufacturer Narrative
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Corrected data: describe event or problem: additional information from customer added.The companion 2 driver was returned to syncardia for evaluation.The customer-reported right overpressure alarms and drop in left fill volume were confirmed via review of the patient data file and driver alarm history and reproduced during investigation testing.The root cause of the right overpressure alarm was determined to be a malfunction of the right electronic pressure regulator.The root cause of the drop in left fill volume was determined to be a malfunction of the left pilot valve.Syncardia has a corrective and preventive action (capa) to address the pilot valve issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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Event Description
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The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited right overpressure alarms while supporting the patient.The customer also reported that the patient stated he didn't feel well and then the companion 2 driver experienced a fill volume drop to zero.The customer also reported that there was no clinical impact on the patient and the patient was subsequently switched to a backup driver without any reported adverse patient impact.
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Search Alerts/Recalls
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