LIVANOVA DEUTSCHLAND GMBH S5 SCP ERC 500MM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 60-05-60 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in switzerland.As per follow up with the customer, the clamp can be operated with the control and partially does not respond or partially the clamp opens automatically that the tube opens.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 has received a report that the electronic remote clamp opens or closes automatically.There is no report of any patient injury.
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Manufacturer Narrative
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H10: a livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.No part was replaced.The involved unit was tested and it opened automatically two (2) times out of ten (10) attempts.This report was due on november 30, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.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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See initial report.
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Manufacturer Narrative
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H10: based on information collected and on the technical intervention, it is reasonable to exclude an erc hardware failure and it cannot be ruled out that a temporary loose connection between the clamp and the control panel may have led to the reported failure.
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Event Description
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See initial report.
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Search Alerts/Recalls
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