Model Number 10-88-00 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova deutschland manufactures the s5 min.I.Hlm.The incident occurred in germany.Livanova initiated an investigation.Analysis of the pump read out of the event date (b)(6) 2023 found an error message that can be associated to two possible root causes: one of the two speed sensors had a malfunction or blocked raceway (by a foreign body) or occlusion too high.This forces the motor section to draw an high current while the motor is blocked.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 roller pump stopped following a motor control failure error message during procedure.There was no patient injury.
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Manufacturer Narrative
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H10: through follow-up communication livanova learned the device serial number which was used during the surgery.Model/serial numbers have been added to the dedicated d.4 section.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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The involved mast roller pump was manufactured in 2020 and according to the analysis of the complaints database no further similar events have been reported in the past related to this unit.Despite being requested, no information regarding any service activity performed on the involved device was provided.Based on all the above facts and collected information, it cannot be ruled out that reported event could be caused by: (i) malfunction of one of the two speed sensors or (ii) blocked raceway (by a foreign body) or occlusion too high.No specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.
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Manufacturer Narrative
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H10: through additional internal follow-up it has been discovered that in the days following the reported event, the entire heart lung s5 machine was inspected by livanova personnel and no failure could be identified.The involved unit was then put back into operation by the customer and the fault did not occur again.As already stated previously, the analysis of the serial read-out of the pump (real time device parameters and setting recording file), highlighted ¿no_pulse_block¿ message.This message is related to: (i) one of the two speed sensors malfunction or (ii) raceway blocked (by a foreign body or occlusion too high).Since no device malfunction could be confirmed during device inspection, livanova concluded that the pump stop was due to an inappropriate user setting.Therefore, since the pump stop was solely caused by a use error and this did not result in death or serious deterioration in state of health or serious public health threat the event is being reassessed as not reportable.
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Event Description
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See initial report.
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Search Alerts/Recalls
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