LIVANOVA DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 60-02-15 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Through follow-up communication with the customer, sorin group(b)(4) learned that the customer tried two different flow probes on the faulty control panel before switching the panel out, confirming that the issue was with the control panel.A new flow board and cpu board have been ordered to provide to the customer as replacements.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that when the customer fitted the sorin centrifugal pump system with tubing clamp to the s5 console during priming, the flow readings did not appear.A second control panel was connected, which worked as expected.The original probe was also connected to the second control panel and was found to be working properly.There was no patient involvement.
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Manufacturer Narrative
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Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A new flow board and cpu board replacements were received, fitted and tested.All tests were completed without additional issues noted.As the device was not returned for investigation, the exact root cause could not be determined and corrective actions were not identified.This is a known issue; there was no patient harm reported.Livanova (b)(4) will continue to monitor for trends related to this type of issue.
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