Alerta De Seguridad para HomeChoice Automated Peritoneal Dialysis Systems (product code: 5C4474)

Safety alert

2013-04-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20130410.html

Safety alert on automated peritoneal dialysis system the department of health (dh) today (april 10) drew the public's attention to a safety alert issued by a local medical device supplier, baxter healthcare limited (baxter), regarding the integrity of the ac power cords of its homechoice automated peritoneal dialysis systems (product code: 5c4474). the dh received a notification from baxter that the company was aware of a modification carried out to the ac power cords used on the device which involved fitting of a local ac plug that could affect the integrity of the ac power cord in use. according to baxter, although all power cords for the device currently being used in hong kong fulfilled the local standards and have passed relevant electrical safety tests before use, the overall integrity of these power cords was uncertain and may lead to two potential risks to users. firstly, the device may fail to function and the dialysis session will be delayed. secondly, there is a potential for an electrical fire or shock. however, the possibility of the occurrence of these risks is very low. a dh spokesman said, "the dh's preliminary enquiries with baxter revealed that some 600 devices have been distributed to public and private hospitals and home users in hong kong. baxter will arrange replacement of the ac power cords for customers during their next on-site maintenance of the equipment." baxter has set up a hotline (9160 3535), for public enquiries. "so far, there is no relevant report of adverse incidents related to the use of this device in hong kong," the spokesman added. the dh has informed public and private hospitals and relevant medical associations about the alert and shall continue to liaise with baxter on the follow-up actions. ends.