LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number 10-85-00 |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
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 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.All roller head pumps used was functionally tested and were within specifications.Customer used affinity cardioplegia adapter belonging to a competitor, therefore it was removed and functional and verification tests were performed also on cp5 derive unit.Functions and speed were found within specifications.No issue was detected.The unit 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 double head pump ran slow during procedure.There was no patient injury.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: complaints database analysis revealed no similar events since unit installation in 2021 and no adverse and concerning trends about the reported failure mode have been triggered by periodical complaints statistical analysis.Based on the information collected, the root cause of the claimed case is unable to be identified.Nevertheless, based on the investigation results of similar complaints review and taking into consideration that the problem was not reproduced by the field service engineer an hardware pump defect can be ruled out.Consequently, it cannot be excluded that a specific configuration of the cardioplegia pump circuit may have contributed to the reported event.
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