Catalog Number 12-02-85 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
Event Type
malfunction
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Event Description
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Livanova (b)(4) received a report that, during maintenance/repair of a 3t heater cooler, the error e04 (the temperature difference between the control and safety systems is too great) was displayed.There was no patient involvement.
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation 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: through follow-up communication livanova learned that the error code initially reported was not the one experienced by the customer.It was communicated that the error code displayed was associated to short circuit at control temperature sensor on cardioplegia side.The issue could be solved by replacement of processor board.Thus, the reported malfunction affected cardioplegia circuit only and not the patient side.Reportability decision changes to not reportable event since the error affected the cardioplegia side and not the patient circuit.Issue on temperature management of cardioplegia solution are not likely to result in serious injury to the patient.Cardioplegia solution is delivered in small volumes and can its temperature can be managed through alternative methods (i.E.Ice for cooling).
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Event Description
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See initial report.
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Search Alerts/Recalls
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