Model Number 60-01-04 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Pictures of the reported error message were provided to livanova.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The drive unit was replaced with another.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) gave a runaway fault error message during priming and the user could not clear the alarm.The drive unit was replaced with another to initiate the procedure.There was no patient involvement.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: the drive unit was requested for investigation.No deviation could be found during functional tests and the device worked within specifications.Based on the investigation performed for similar cases, the reported error message is most likely due to: hand cranking performed by the user while the cp5 control panel is still on; malfunction of the motor control board.No hand cranking was performed by the customer since it was reported that the drive unit was replaced and another drive unit was used to continue the procedure.Based on gathered data and investigation results, a systematic failure of the motor control board can be excluded.Thus, the reported event was most likely due to an intermittent failure of the motor control board which will be replaced as per equipment maintenance intervention prevention.
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Search Alerts/Recalls
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