HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set) 의 안전성 경고

Safety alert

2013-04-10

2013-04-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130410b.html

Medical device safety alert: baxter homechoice automated peritoneal dialysis system (ac power cord set) medical device manufacturer, baxter healthcare, has initiated a medical device field safety correction action concerning homechoice automated peritoneal dialysis (pd) system (product code 5c4474). following a recent review, baxter has become aware of a modification carried out to the ac power cords used on homechoice automated pd devices. the modification has involved fitting of a local ac plug which could affect the integrity of the ac power cord set in use. although all power cords for homechoice device currently using in hong kong fulfill the standard bs1363 and follow the guideline of hong kong electrical and mechanical services department, the overall integrity of these power cords is uncertain. it is baxter’s intention to replace it with an approved version power cord over the coming 12 months. there are two potential risks to the user. 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 to occur, which may result in burns or cardiac death in extremely rare case. baxter has already developed an approved power cord to suit multi-countries requirements with an integral plug for use on homechoice pd system. also, baxter technical service engineers will replace ac power cords for the homechoice device in the facility and patient’s home during the next onsite maintenance. 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.