Livanova received a report stating that during priming the tubing just slipped back off the 3/8 connector even when it was tie banded.Picture of the issue was received, confirming it.Pack was not available for return.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.By reviewing the complaints database, a further similar event for tubing disconnection related to this connector has been recorded on the same pts pack code, but different lot number.This involved 3/8 connector is assembled with the tubing through the use of solvent and then tie banded.Based on above and without sample to analyze, it cannot be ruled out that the disconnection was due to the following possible root causes: - insufficient presence of solvent, - tie band not tight enough, - tubing and/or connector dimensional issue.The risk is in the acceptable region.Livanova will keep monitoring the market.
|