Livanova usa inc.Received a report that cardioplegia cannula adapters during procedure leaked in various areas, wherever the tubing connects to a connector, at the y or at the tip.Surgeons have been sprayed with blood.Affected units were changed out until one that didn't leak.There was no patient injury.
|
A.1.-a.5.There was no patient involvement.D.4.Involved lot is 232400008 or 2326200052.This information will be provided in a supplemental report if made available.H10: livanova deutschland manufactures the cardioplegia cannula adapters.The incident occurred in kansas city, kansas.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
Correction in h10 of the initial report: livanova usa manufactures the cardioplegia cannula adapters.The incident occurred in kansas city, kansas.From complaints database review, in total (4) complaints (mfr #1718850-2023-00040, 1718850-2023-00041, 1718850-2023-00042 and 1718850-2023-00043) related to the same issue were submitted from this facility, that occurred on consecutive days.One unit among those affected was returned by customer for investigation, however it did not have any traceability information, therefore it was not possible to distinguish to which of the two complained lots it belonged to.Visual inspection was performed: a clear leak path could be seen at the y-connector with the red and blue clamp.Each part of the device was leak tested individually.The unit leaked out of the y-connector bond with the red and blue clamp.All luer connectors attached to the end of each of the legs did not leak.The review of similar cases highlighted that other previous complaints, not the ones mentioned above, were registered in the last 12 months reporting leaks from the y-connector, particularly from different customers and thus also on different cannula lots.Based on the investigation results from similar complaints, the event identified a leak at the connection between the y connector and the tubing.A gap between the two impacted components was observed and recognized as source of the leak.This connection is obtained through the use of uv adhesive during the manufacturing process.Also, all other tubing connections to luers and to the four-ways connector are solvent bonded.A capa was initiated for the issue of leaks from y-connector, and the investigation revealed the following findings: 1) uv adhesive flows from tube-to-connector joint before curing.2) variations in the quality of the connectors compromise the integrity of the bond.Corrective action will be implemented through the capa process.Regarding leaks from other bonded connections, the personnel will be involved in a dedicated training meeting awaring of customer complaint.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
|