Full report completed and attached:

Investigation

The reported tubing line was returned from the customer via the territory manager, who had completed the DCS form. The tubing line had been rinsed prior to its return to Chalice Medical by the end user.

Upon receipt of the returned line, the line and subsequent connection were macroscopically assessed.

The device was returned rinsed and held within a seal grip bag. The Tyvek lid associated to the device was returned along with the tubing line to ensure the traceability of the product could be conducted.

Further visual examination was undertaken on the line in particular the area where the connection was once present.

The remanence of boding solution was present on the tubing connection, which indicated that the Luer was indeed bonded on.

However, it was noted that the application of the adhesive was not applied in a consistent manner on this connection.

The bonding solution application was not consistent in its application, this can be seen in the imagery above and to the right. I believe the leakage seen in clinical use initially started from this weak application depicted with the red outline, which under an increase in pressure gradient in clinical use has created a channel for leakage to occur.

In clinical use, a leak was noted coming from the oxygenator. It was unclear if it was the oxy tubing or connectors. Upon inspection the recirculation line was noted as being the area in which leakage was occurring.

At this point the end user tried to stem the leakage by applying a tie wrap to the connection to seal the tubing line. As this was undertaken it caused the tubing line to separate completely from the connection, this occurred due to the already weakened bond present in this location.

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Root Cause

The root cause of the issue raised in part of this record is due to a weak bond being present between the connection of the luer and that of the tubing. The inadequacy of this bond had allowed for leakage to occur between the luer and the tubing, upon application of a tie wrap by the end user, where the tubing disconnected completely. The line had not leaked on prime and only did so after 40 minutes of use which would indicate that a bond was initially present, due to the incomplete nature of the application, an increase in pressure in clinical use has led to a channel of separation to occur allowing leakage from the connector.

Actions

As detailed in the empirical testing undertaken a sleeved connection displays a higher degree of or resistance, this coupled with the expansions of tubing in the process aids in the even dispersion of adhesive in this area creating a secure seal on this connection that performs greater than the original.

1] Spare Replacement line 8’s of CM2470C will be manufactured and supplied to you, as spares for the remaining quantity of the lot number that you currently have in stock. These will be manufactured with the sleeving on the Luer connection for added security.

2] The CAD drawing for the pack is to be updated to include a new requirement to sleeve this connection for all future builds.

3] The (PCRF) Pack Code Record Form associated to CM2470 will be updated in reference to this issue, to make all operatives aware of this issue at the point of manufacture.

Conclusion

The issue highlighted in this report has a root cause of a manufacturing error, the manufactured pack has failed to meet the customers specifications due to the inadequate application of bonding between the luer and tubing line. Risk associated to this issue are already part of the risk management file. However, a new risk file will be created specific to Manufacturing Errors – Bonding to enable further risk prevention measures to be applied accordingly in the future if required. Thank you for bringing this matter to our attention, thus enabling Chalice to investigate the problem. We do value our customer’s comments, which helps provide quality products, combined with superior service.

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