LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number 10-80-00 |
Device Problem
Pumping Stopped (1503)
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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 roller pump.The incident occurred in the woodlands, texas.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix the issue, motor control board (hms) and motor power amplifier board (hmf) were replaced.Subsequent 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 deutschland received a report that a s5 roller pump did not spin and gave a motor control failure error message at setup.There was no patient involvement.
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Manufacturer Narrative
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According to complaint database review no further issue has been submitted for this unit since its installation in 2013.Based on collected information and considering similar complaints analysis, the reported issue was caused by defective motor control (pn:90-305-770) and motor amplifier board (pn: 90-305-760) most likely due to aging of electronic component.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.However, there is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Event Description
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See initial report.
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