LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Catalog Number 10-80-00 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2023 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that, during priming a s5 roller pump, even if stopped by the user, it started again in the opposite direction for a while and then stopped.It was an intermittent failure; it happened three (3) times.There was no patient involvement.
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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 france.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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H10: the unit was sent to the manufacturing site for further investigation.The reported issue was confirmed and the motor control board (hms) was replaced to solve it.Subsequent functional verification testing was completed without further problems and the unit was returned to service.The hall sensors of the pump motor, which detects the position of the rotor's rotating magnetic field, are connected to the board involved via a socket.Consequently, based on technical intervention reported above, it cannot be ruled out that this hms board failed and did not allow for correct signal processing.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event.The pump involved was manufactured in 2015 and the review of complaints revealed no other similar occurrences involving this unit.Thus, the event is an isolated case.
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Event Description
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See initial report.
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Search Alerts/Recalls
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