Model Number 16-02-85 |
Device Problems
Pumping Stopped (1503); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed that both patient pumps were non-functional when the front panel switches were pressed.However, the pumps could be started by given them a gentle nudge.One of the two pumps was replaced and the bridge was reassembled and reinstalled into the unit.A second pump was ordered and the service representative returned to the facility at a later date to replace the second faulty pump.The pump functionality was tested and no issues were identified.The device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that a heater-cooler system 3t displayed an error message on patient side during a procedure and stopped pumping.The user completed the case using a back-up device.There was no report of patient injury.
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Manufacturer Narrative
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The device was returned for further investigation.During the evaluation the reported failure could be confirmed.It was found that the electronics of the motor is defective.In addition corrosion was detected on vibration metal buffers and pump columns.
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Event Description
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See initial report.
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Search Alerts/Recalls
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