Model Number 595000-001 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Volume Accuracy Problem (1675)
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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 02/28/2017 |
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 freedom driver exhibited fill volume readings that were outside the expected range, it continued to perform its life-sustaining functions.The freedom driver will be 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 customer, a syncardia certified distributor, reported that the freedom driver exhibited fill volume readings that were outside the expected range while supporting a patient.The customer also reported that the patient was switched to a back-up freedom driver without any 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 driver revealed no abnormalities and the driver passed all functional testing.Extended observation testing confirmed that the driver remained within the fill volume (fv) requirements as permitted by freedom driver final test and acceptance procedure.There was no evidence of a device malfunction and the freedom driver performed as intended.The customer-reported experience of "wrong" fvs on the freedom driver could not be reproduced during investigation testing.The freedom driver's fvs were not compared to the fill volumes of a companion 2 driver, as the companion 2 driver settings and patient conditions at the time of the customer experience were not provided by the customer.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 customer, a syncardia certified distributor, reported that the freedom driver exhibited "wrong" fill volume readings while supporting a patient.The customer also reported that the displayed fill volumes on the freedom driver did not match the fill volumes displayed on a companion 2 driver when supporting the same patient.The customer also reported that this was the second freedom driver to have this reported issue while supporting the patient.[see freedom driver s/n (b)(4) (mfr.3003791017-2017-00043)].The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact and the issue was no longer observed.
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Search Alerts/Recalls
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