LIVANOVA DEUTSCHLAND GMBH S5 KONSOLE GR. 3; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number 48-30-00 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 system.The incident occurred in germany.A livanova initiated an investigation.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 deutschland received a report that, during priming, the main rotary knob for flow control on the arterial pump of the s5 console is defective button has been knocked out.There is no report of any patient injury.
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Search Alerts/Recalls
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