Model Number 60-02-60 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/17/2019 |
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).A livanova field service representative was dispatched to the facility to investigate the device.He tightened the encoder and the issue was solved.Functional verification testing was completed without further issues and the unit was returned to service.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 the speed control knob on a centrifugal pump 5 (cp5) was found to be loose during setup.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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H.10: the reported event has been re-evaluated as non reportable since the movement of the shaft encoder of a cp5 control panel are limited by mechanical constraint related to its housing, consequently pump speed remains controllable by the user.
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Search Alerts/Recalls
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