Catalog Number 397002-001 |
Device Problems
Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)
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Patient Problem
Hemolysis (1886)
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Event Date 12/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because the companion 2 driver continued to perform its life-sustaining functions.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) initial.
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Event Description
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The customer, a syncardia authorized distributor, reported that the patient had continued hemolysis while supported by the companion 2 driver.The customer also reported that when the hemolysis did not improve, the patient was switched to the backup companion 2 driver and patient conditions improved.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.The customer-reported development of increased patient hemolysis caused by a possible device malfunction was unable to be confirmed or reproduced during investigation testing.The driver passed all functional testing and was subjected to an additional 48-hour observation run to observe any possible malfunction or change in performance.The driver performed as intended, and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
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Event Description
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The customer, a syncardia authorized distributor, reported that the patient developed hemolysis a few days after tah-t implant while supported by the companion 2 driver.The customer also reported that while the companion 2 driver was connected to wall air, the internal compressor of the driver would cycle on and off (mfr.Report #: 3003761017-2018-00006).The customer also reported that when the hemolysis did not improve, the patient was switched to the first backup companion 2 driver and the hemolysis continued.The customer also reported that the patient was then switched to the second backup companion 2 driver and the patient conditions improved.
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Search Alerts/Recalls
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