LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Catalog Number 60-03-75 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.Patient information was not provided.The event is related to a pump stop.H10: livanova deutschland manufactures the scpc centrifugal pump console.The incident occurred in germany.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 centrifugal pump console stopped during use and the emergency drive unit was used.There was no patient injury.
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Event Description
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Initial report.
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Manufacturer Narrative
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Thought follow up from the customer, livanova was informed that, when the scpc has stopped, the screen frozen on the control panel, no error code was displayed and it had to be cranked.Device is not being used.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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H11: through follow-up communication, livanova learned that the customer did not request any service repair or intervention on the device.No components or parts was replaced by the customer who is currently using the scpc.Reportedly, no further issues have been experienced by the customer.The unit was manufactured in 2012 and according to complaints database review no further similar issue was reported in the past.Based on the information collected and considering that the unit was not inspected by a livanova field service engineer, the exact root cause of the reported issue cannot be determined.
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Event Description
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See initial report.
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Search Alerts/Recalls
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