LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number 12-80-10 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).It was reported that the customer had some issues with the device in the past and following to that the clamp was checked and found to be properly working.At the time, the device was re-calibrated and nvmem cleared.The device worked as per specifications and was returned to the customer.However, it was communicated that despite the clamp worked well for some time, there were errors sometimes during calibration and sometimes during work until recently reported error associated to the clamp encoder.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 received report that electrical venous occluder (evo) gave some problems sporadically.Reportedly, the clamp displayed errors during calibration and also during use and recently gave an error code associated to the clamp encoder.There was no report of patient injury.
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Manufacturer Narrative
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H.10: through follow-up communication livanova learned that the customer only recall about error associated to the clamp encoder and not other errors.The affected device was returned to the manufacturer site for repair and upon testing the reported issue could not be reproduced.However, the clamp encoder and the ribbon cable were replaced as potentially involved components.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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Manufacturer Narrative
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Based on available information and similar reports from other customers, it cannot be ruled out that the most likely root causes was an intermittent faulty connection between the encoder board and the ribbon cable.
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