Ebb Complete Tamponade System (CTS-lOOO) 에 대한 현장 안전성 서한

Field Safety Notice

2015-07-09

Slovenia

AMPMDRS

This is to inform you of a voluntary global recall of clinical innovations’ ebb complete tamponade system (cts- 1000) involving lot numbers 1214—v-424; 1214-f-403 .The purpose of the recall is to address the potential for a balloon leak which may affect your ability to deliver therapy, when needed. clinical innovations’ records indicate you have received a product that is affected by this action. following a report that an ebb complete tamponade system (cts-looo) had leaked during use, clinical innovations conducted an investigation on the returned device and concluded that the leakage was caused by a failure mode of the bond at distal end of the uterine balloon a balloon leak can be identified by a failure to arrest bleeding, ultrasound revealing loss of balloon volume, or blood-tinged liquid being expelled from the drainage tube. a uterine balloon with a leak may not provide the anticipated tamponade effect, requiring further intervention. although unlikely, death could occur due to the failure mode associated with this recall. in the report received, the patient had stabilized prior to the leak being noticed by the clinical team. because there is a potential for additional interventions with a balloon leak (such as arterial embolization or surgery) required to control a postpartum hemorrhage, we are requesting that you return all unused ebb complete tamponade system (cts-looo) from the above—listed lot numbers. no other clinical innovations products are affected by this issue.