Model Number D901 + ADAPTORS |
Device Problem
Blocked Connection (2888)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2021 |
Event Type
malfunction
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Event Description
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Sorin group (b)(4) has received a report that, during a procedure, arterial blood sample could not be obtained from the arterial sampling port of two d901 lilliput oxygenators.Medical team elected to change out the oxygenators.The procedure was completed with no issue.There is no report of any patient injury.
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Manufacturer Narrative
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Patient information were not provided.Sorin group (b)(4) manufactures the d901 dideco lilliput oxygenator.The incident occurred in (b)(6).During follow up with the customer, livanova was informed that: change-out of the oxygenator took about 5 mins.The issue occurred at the very beginning of the by-pass.There was no impact on patient health.The involved devices is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available.
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Manufacturer Narrative
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Livanova received a report about no blood flow condition through arterial sampling port of lilliput d901 oxygenator during procedure.No patient / user impact occurred.Two units affected.Parts were not made available for return.Through follow-up communication, livanova learned that no change-out of the units was conducted.Perfusionist overcame the problem by taking arterial sample for blood-gas analysis from other points along the arterial line.Review of complaints database revealed no further similar case notified for batch concerned from the market.Based on investigation of previous similar events, the most probable root cause of the event is a suboptimal coupling of (i) the insert with membrane silicone valve and of the (ii) sampling line with the oxygenator port after the insert is manually positioned above the valve.Livanova has opened a non conformity report to further investigate the root cause and possible corrective actions.The risk is acceptable.Livanova will maintain monitoring the market.
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Search Alerts/Recalls
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