Model Number 16-02-85 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2022 |
Event Type
malfunction
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Event Description
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Livanova deutschland received a report that a heater-cooler system 3t was leaking water back up to the pump and electronics area and gave a popping sound when turned on.Reportedly, the customer is not trained on the device.A reportable malfunction cannot be excluded thus the event is conservatively considered as reportable.The issue was identified during maintenance and there was no patient involvement.
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.Occurred in (b)(4).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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H.10: a livanova field service representative was dispatched to the facility to investigate the device and found that the unit panels were removed from the sides.Upon checking the device, it was found that the patient pump 1 was not functional and noticed that the stirrer motor hose was pointed up towards the patient pump 1 motor.This could have resulted in the over current/short-circuit of the patient pump 1 and distribution board.The patient pump and the distribution board were replaced and the stirrer motor hose adjusted to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was 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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See initial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that this event was a duplicate of an event already captured in livanova complaint database and already reported under reference 9611109-2022-00264.Consequently, investigation results will be reported under the above mentioned reference and this case will be voided.
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Search Alerts/Recalls
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