Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae 의 안전성 경고

Safety alert

2014-03-07

2014-03-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140307c.html

Medical device safety alert: terumo sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning all lots of sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae with catalogue numbers 4934, 4934x, 4935, 4936, 4936x, 16472 and 16473. during in-process inspection, terumo cardiovascular systems (terumo cvs) identified exposed basket wire on certain product lots of sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae. according to the manufacturer, the presence of exposed basket wire on the outside surface of the cannulae may be detected by the surgical team prior to patient exposure. if not detected, the exposed wire could result in tissue damage and a remote chance of air being introduced into the cardiopulmonary bypass circuit. the presence of exposed basket wire on the inside surface of the cannulae is more difficult to detect. the exposed wire could result in turbulence in blood flow increasing risk of hemolysis. terumo cvs has not received any reports of exposed basket wire from customers and there are no reported injuries from the observed defect. terumo cvs is recalling all affected cannulae. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.