Important Safety Alerts

Medical device manufacturer,Baxter Healthcare Ltd., has issued a letter to customers concerning CAPD Solution Transfer Set with Locking Connector(product code 5C4160)and MINICAP Extended Life PD Transfer Set with Twist Clamp (product code 5C4482).

Baxter would like to provide an important information regarding changes that are being made to Instructions for Use(IFU) for Baxter peritoneal dialysis transfer set with the above product codes to improve product labeling and ensure consistency of information across the Baxter transfer set product family.Key additions to the IFU include:

• The set is to be used with the Baxter Locking Titanium Adapter for Peritoneal Dialysis Catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
• Wipe for a minimum of 1 minute around the connection between the titanium adapter and the Transfer Set or locking cap with a sterile gauze pad soaked in povidone-iodine.
• It is recommended that thyroid function be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children.
• Reuse or reprocessing of a single use device may lead to contamination and compromised device function or structural integrity. Do not use if tip protectors are not in place.
• This product does not contain natural rubber latex.

Baxter advises customers to communicate to the patient forapplicable changes to the IFU and emphasize the importance of following the IFU at each PD transfer set installation or exchange.

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 5 March 2013