Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system(Patient At-Home Guide)

10 Apr 2013

Medical device manufacturer, Baxter Healthcare, has issued a safety alert letter to customers to inform them of the best practice for properly managing a planned or emergency disconnect from their HomeChoice Automated Peritoneal Dialysis (PD) system(product code 5C4474).

The HomeChoice patient at-home guide (part number 071964016) describes using a flexicap or opticap for high dose therapy (Optichoice therapy) or for an emergency disconnect. However, the flexicap or opticap are not available in Hong Kong.

If patients disconnect during therapy and do not reconnect using new supplies, there may be a possible of contamination of the patient line, which may lead to peritonitis.

Baxter advises patients that if they need to disconnect from their therapy before it is completed, they should end the therapy and then restart the therapy using all new supplies (such as solution bags and the disposable set).

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 10 April 2013

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