Venisystems Blood Bottle Pumpset with CAIR Clamp 의 안전성 경고

Safety alert

2013-11-18

2013-11-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131118a.html

Medical device safety alert: hospira venisystems blood bottle pumpset with cair clamp it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning venisystems blood bottle pumpset with cair clamp. the details of the affected devices are as follows: list number: a) 04643-97-01; b) 12697-65; c) 12720-65 lot number: a) 040945g, 131335g; b) 281145h, 180015h, 040115h, 880485h, 782245h, 680585h; c) 161475h, 153405h, 032595h there are increased complaints of backflow of fluid, incorrect assembly and no flow associated with the affected intravenous administration sets, which have resulted in retrograde flow. incorrect assembly of the bulb pump has the potential to prevent delivery of blood to the patient resulting in a delay of therapy. it may result in death or serious injury if a prolonged delay in the administration of life-sustaining blood products occurs. no reports of injury to patients have been received to date. the manufacturer advises users not to use and immediately quarantine the affected products, and return them to the manufacturer. hospira is improving the manufacturing process to address incorrect assembly. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2013.