Kimvent Subglottic Suctioning Endotracheal Tubes 의 안전성 경고

Safety alert

2014-11-21

2014-11-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20141124.html

Medical device safety alert: halyard health (kimberly-clark) kimvent* subglottic suctioning endotracheal tubes medical device manufacturer, halyard health, inc. (formerly known as kimberly-clark health care) has issued a field safety notice concerning its kimvent* microcuff* subglottic suctioning endotracheal tube, 8.0mm. the affected product code is 13222. the affected lot numbers, shipped from 20 december 2013 to 30 october 2014, are aa3213, aa3213v03, aa3227, aa3227v01, aa3239, aa3239v01, aa3245, aa3245v02, aa3249, aa3249v01, aa3249v03, aa3253v02, aa3269v01, aa3274, aa3274v01, aa3274v04, aa4038, aa4038v03, aa4038v04, aa4038v06, aa4062, aa4062v01, aa4062v03, aa4062v04, aa4083, aa4083v02, aa4097, aa4097v02, aa4097v04, aa4104v01, aa4104v02, aa4111, aa4111v01, aa4111v02, aa4113v01, aa4125v03, aa4134v01, aa4146v01, aa4146v04, aa4155v03, aa4167v01, aa4170v01, aa4174v01, aa4217v01 and aa4226v01. according to the manufacturer, the standard kimvent* microcuff* endotracheal tubes are not impacted. the manufacturer has identified that the inflation line of certain kimvent* microcuff* subglottic suctioning endotracheal tubes may detach from the endotracheal tube during use. in most reported cases, detachment of the inflation line was identified immediately, while in other cases, eventual decrease in ventilator circuit pressure triggered ventilator alarms. in the majority of occurrences, re-intubation of the patient was required to re-establish the desired pressure in the ventilator circuit. one suspected case of ventilator associated pneumonia was reported after inflation line detachment, which resolved with standard antibiotic treatment. the manufacturer has initiated a voluntary product recall on the affected lots of devices. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 november 2014.