LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 60-01-04 |
Device Problems
Decreased Pump Speed (1500); Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2022 |
Event Type
malfunction
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Event Description
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Livanova received report that when turned on and rpms increased to 2000 the pump head of centrifugal pump 5 (cp5) did not turn.The rpm number stayed yellow, then went to zero with the dial still at 2000.At this time, the pump head started to turn very slowly.The rpms were manually set down to zero and back up very slowly to 2000.The pump head still only turned slowly.The rpm number remained yellow.I watched for a few minutes and without me touching anything the pump head speed increased to match the rpm number and then ran appropriately until i turned it off.There was no patient injury.
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(4).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The drive unit was replaced as precaution.Reportedly, a similar issue happened about 4 months before and the drive motor and the processor board in the cp5 console were replaced.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: based on similar events investigations, the reported issue can be due to: defective processor board which is located in cp5 pump control panel; defective circuit board motor control board which is located in the drive unit; communication failure between processor board and motor control board.Considering that functional test performed by technician did not reproduce the issue and no problem was detected with the drive unit, a defective circuit board motor control can be excluded as potential root cause.Taking into account that no problem was detected with cp5 control panel, which was not replaced and is still in use in customer facility, defective processor board can be excluded as well as potential root cause.Therefore, the most likely root cause of the event can be traced back to intermittent serial communication failure between processor board and motor control board.
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Event Description
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See initial report.
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