藥物警訊

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
Sets and Trays contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
Audience: Hospital Risk Manager, Anesthesiology
Issue: FDA notified healthcare professionals that Cook initiated a voluntary recall of certain lots of Ciaglia Blue Rhino/Blue Dolphin Percutaneous Tracheostomy Introducer
Sets/Trays that contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube due to the product’s cuff not holding air. The voluntary recall only affects lot numbers noted in the press release at link below.
Background: The defect is a result of leaks in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation and could result in serious injury, including death.
Recommendation: Cook has mailed a detailed Customer Notification letter to each customer who has received an affected lot number of these devices. Customers should review product in inventory and current use to identify product from the affected lot codes. Healthcare professionals may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or fax.
‧ Online: www.fda.gov/medwatch/report.htm
‧ Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
‧ Mail to address on pre-addressed form or fax to 1-800-FDA-0178
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒醫護人員Cook自願性回收部份批號的Ciaglia Blue Rhino/Blue Dolphin經皮擴張氣切術引導器套組，包含了Covidien 6PERC或8PERC Shiley系列的氣切套管，因為產品的氣囊無法保持充氣，回收的批號如上表：
有此缺陷是因為組裝的氣囊有裂縫，若氣囊無法保持充氣會對呼吸有不良的影響，因為氣囊無法密封會影響對呼吸道產生正壓的能力，進而可能會造成血液中氧氣的瞬間減少，或二氧化碳的瞬間增加，尤其是需要輔助型機械呼吸的病患，此外，也可能造成嚴重的傷害，甚至死亡。Cook已透過郵件通知購買需回收批號裝置的消費者，應檢查是否有上述批號的裝置。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220022.htm
[Posted 07/22/2010]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部供：台大醫院藥劑部