Catalog Number 397002-001 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Hemolysis (1886)
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Event Date 10/10/2016 |
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 will be 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 reported that the patient had been supported by the companion 2 driver for "a while" when a nurse noticed hemolytic urine output.The customer also reported that they felt there was no clinical evidence for the hemolysis.The customer also reported that the patient was stable and was therefore switched to a freedom driver without any reported adverse patient impact.The customer also reported that after the driver switch the patient's hemolysis improved.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.Review of the patient file revealed no alarms.Incoming inspection and observational testing was performed in an attempt to duplicate the customer-reported issue.Testing determined there was no evidence of a device malfunction nor was there a contributing factor identified that would lead to the customer-reported issue of patient hemolysis.The root cause of the customer experience could not be determined.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 reported that the patient had been supported by the companion 2 driver for "a while" when a nurse noticed hemolytic urine output.The customer also reported that they felt there was no clinical evidence for the hemolysis.The customer also reported that the patient was stable and was therefore switched to a freedom driver without any reported adverse patient impact.The customer also reported that after the driver switch the patient's hemolysis improved.
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Search Alerts/Recalls
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