LIVANOVA USA INC SMART, PERFUSION PACKS, CONNECTORS, TUBING; COBE SMARXT TUBING AND CONNECTORS
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Catalog Number 046001104 |
Device Problem
Misassembled (1398)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Issue occurred prior to patient involvement.The involved device is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not available.
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Event Description
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Livanova usa in has received a report that, during the test before initiating the procedure, it was found that the arterial and the venous lines were swapped they rectified it by switching the 3/8" tubing on the arterial and venous cannulas.The issue occurred prior to any patient involvement.
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Manufacturer Narrative
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The complained device was not made available for investigation.The customer has provided photographic evidence in which it is visible that the arterial and venous lines were swapped when compared with the technical drawing of the circuit.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.No other similar complaint has been received for the claimed circuit and/or lot.Livanova investigation confirmed the reported condition.The most probable root cause of the claimed issue was an isolated human error during the manual assembly of this specific unit of this item circuit.To prevent further occurrences,along with the already present in process control, the involved operators will be retrained.Livanova will keep monitoring the market.
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Search Alerts/Recalls
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