Model Number 595000-001 |
Device Problems
Connection Problem (2900); Device Dislodged or Dislocated (2923)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
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 right spring on the cpc connector was displaced, the freedom driver continued to perform its life-sustaining functions.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that during a driver exchange, the right cpc connector (circular plastic connector) on the freedom driver had a displaced spring.There was no reported adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Visual inspection of the cpc connector on the driveline revealed no abnormalities.The locking spring in the cpc connector was observed to be located in the correct position and fully functional.The customer reported issue of difficulty with the right press release (cpc connector on the right driveline) was not confirmed and was not reproduced during this investigation.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) follow-up report 1.
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Event Description
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The cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that during a driver exchange, the right cpc connector (circular plastic connector) on the freedom driver had a displaced spring.There was no reported adverse patient impact.
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Search Alerts/Recalls
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