德爾格醫(yī)療召回VentStar呼吸回路和麻醉套裝

來源：美國食品和藥物管理局【?2019-02-13 發(fā)布?】　美迪醫(yī)訊

美國食品和藥物管理局已將此視為第一類召回，這是最嚴(yán)重的召回類型。使用這些設(shè)備可能會導(dǎo)致嚴(yán)重傷害或死亡。

- 美迪小編

德爾格醫(yī)療召回產(chǎn)品

德爾格醫(yī)療Draeger Medical，Inc。VentStar和ID呼吸回路和麻醉套件
型號/項目編號：
1、MP00349，MP00350，MP00351，MP00352，MP00361，MP00374（VentStar電路和麻醉套件）
2、MP01341，MP01348，MP01350（ID電路和麻醉套件）
制造日期：2016年1月至2018年11月
分發(fā)日期：2016年4月至2018年12月
美國召回的設(shè)備：1,200

設(shè)備使用

德爾格醫(yī)療Draeger Medical的VentStar和ID呼吸回路和麻醉套件是一次性使用的輔助設(shè)備，與呼吸機或麻醉機配合使用，為嬰兒，兒童和成人患者提供機械通氣和關(guān)鍵呼吸支持。這些設(shè)備僅在醫(yī)療保健專業(yè)人員的監(jiān)督下使用。

德爾格醫(yī)療VentStar呼吸回路

召回的原因

德爾格醫(yī)療Draegar Medical正在召回其一次性VentStar和ID呼吸回路和麻醉套件，因為這些設(shè)備裝配不當(dāng)會導(dǎo)致呼吸軟管短路。如果呼吸軟管短路，患者將無法獲得預(yù)期的呼吸支持（通氣）。缺乏呼吸支持可能導(dǎo)致不可逆轉(zhuǎn)的患者傷害，包括嚴(yán)重的氧氣損失（缺氧）和死亡。

誰可能受到影響

使用VentStar或ID Breathing Circuit和Anesthesia Set的醫(yī)院和醫(yī)療保健專業(yè)人員為患者提供呼吸支持。
接受VentStar或ID呼吸循環(huán)和麻醉套裝呼吸支持的患者。

該怎么辦

在2018年12月21日，德爾格醫(yī)療Draeger Medical向客戶發(fā)送了“緊急醫(yī)療設(shè)備召回通知”和“客戶回復(fù)和訂購表”。召回通知指示客戶：

按照設(shè)備的使用說明正確設(shè)置呼吸回路，并檢查以確保在每次使用前正確組裝連接。
如果在使用前檢查期間未檢測到短路呼吸回路，則無法對患者進行通氣。
檢查呼吸回路是否已組裝好，以便呼吸機或麻醉機的吸氣和呼氣接頭在每次使用前和每次臨時斷開后都連接到Y(jié)形件上。
按照提供的檢查說明檢查現(xiàn)有庫存并填寫并返回“客戶回復(fù)和訂購單”以確認(rèn)檢查已完成。
使用“客戶回復(fù)和訂購單”為任何預(yù)先組裝錯誤的呼吸回路訂購免費更換
可以檢測到錯誤預(yù)組裝的呼吸回路，因為它不是單個粘性軟管系統(tǒng)而是兩個獨立的子系統(tǒng)。

Draeger Medical Recalls Breathing Circuits and Anesthesia Sets

Recalled Product(s)

? Draeger Medical, Inc. VentStar and ID Breathing Circuits and Anesthesia Sets
? Model/Item Numbers:
? MP00349, MP00350, MP00351, MP00352, MP00361, MP00374 (VentStar Circuits and Anesthesia Sets)
? MP01341, MP01348, MP01350 (ID Circuits and Anesthesia Sets)
? Manufacturing Dates: January 2016 to November 2018
? Distribution Dates: April 2016 to December 2018
? Devices Recalled in the U.S.: 1,200

Device Use

Draeger Medical's VentStar and ID Breathing Circuits and Anesthesia Sets are single-use, disposable, accessory devices used with a ventilator or anesthesia machine to provide mechanical ventilation and critical breathing support to infant, child, and adult patients. These devices are designed to be used only under a health care professional's supervision.

Reason for Recall

Draegar Medical is recalling its disposable VentStar and ID Breathing Circuits and Anesthesia Sets due to a risk of the devices being incorrectly assembled, resulting in a short-circuit in the breathing hose. If the breathing hose is short circuited, the patient will not receive the expected breathing support (ventilation). Lack of breathing support may result in irreversible patient harm, up to and including severe oxygen-loss (hypoxia) and death.

Who May be Affected

? Hospitals and health care professionals using the VentStar or ID Breathing Circuit and Anesthesia Set to provide patients with respiratory support.
? Patients receiving respiratory support from a VentStar or ID Breathing Circuit and Anesthesia Set.

What to Do

On December 21, 2018, Draeger Medical sent customers an “Urgent Medical Device Recall Notification” and” Customer Reply and Order Form.” The recall notification instructed customers to:
? Follow the device's Instructions for Use for correct setup of the breathing circuit, and check to ensure the connections are assembled correctly prior to each use.
o If a short-circuited breathing circuit is not detected during a pre-use check, it will not be possible to ventilate the patient.
? Check whether the breathing circuit is assembled so that the inspiratory and the expiratory connector of the ventilator or anesthesia machine are each connected to the y-piece before each use, and after any temporary disconnection.
? Inspect your existing stock by following the provided inspection instructions and complete and return the “Customer Reply and Order Form” to confirm that inspections have been completed.
? Use the “Customer Reply and Order Form” to order free replacements for any breathing circuits that were pre-assembled incorrectly.
o An incorrectly pre-assembled breathing circuit can be detected because it will not be a single cohesive hose system but two separate sub-systems.