Alerta De Seguridad para MiniCap, an accessory of peritoneal dialysis systems

Safety alert

2015-01-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150121.html

Safety alert on component of peritoneal dialysis system (with photos) the department of health (dh) today (january 20) 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 minicap (product code: 6ac4466h) (the white cap shown in the attached photo), an accessory of peritoneal dialysis systems used for protection of the female locking connector of the solution transfer set. the dh received a notification from baxter that the company received complaints indicating that the sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing. according to baxter, the use of minicaps with sponges fully separated or missing from the caps may compromise the ability of the minicap to provide a sterile barrier protection at the end of the transfer when the transfer set is not connected to the patient line of the automated peritoneal dialysis cassette or continuous ambulatory peritoneal dialysis twin bag set-ups. moreover, the use of minicaps with sponges partially protruding from the caps may encourage non-aseptic techniques, such as inadvertently touching the sponge to reposition it inside the cap. the above problems may increase the risk of peritonitis. to ensure there is no damage to the minicap and that the sponge is fully within the cap, baxter advises users to inspect the product upon opening the minicap pouch before each exchange. they are also advised not to use the product if the sponge is protruding or missing from the cap, and obtain a new minicap. baxter will arrange for a replacement product upon request by users. a dh spokesman said, "the dh's preliminary enquiries with baxter revealed that the affected product has been distributed to about 3 000 patients." baxter has set up a hotline (2807 8500), for public enquiries. "so far, there is no relevant report of adverse incidents related to the use of this product in hong kong," the spokesman added. the dh has informed public and private hospitals and relevant medical associations about the alert and will continue to liaise with baxter on the follow-up actions.