创建报告

请提供报告标题
请提供位置
请提供详细信息

获取有关您案例的警报和更新!

这些信息不会显示在网站上。我们可以通知您更新,并可能与您联系以获取更多信息,以帮助您解决或跟进您的问题。

请提供电子邮件或电话
请提供电子邮件或电话

我们不会显示您的电子邮件或联系信息

跳过此步骤

添加照片或视频

我们推荐照片和视频来帮助您解释报告

添加照片/视频
跳过此步骤

报告的电子邮件或短信副本

在下面输入以获取您的报告副本的电子邮件,或短信指向您的报告的链接

请提供电子邮件或电话
请提供电子邮件或电话

感谢您的举报!

重要信息-您的报告已排队可能需要 12 个小时才能在我们的主页上显示您的报告(如果没有选择为私人)



重要信息-您的报告已排队
处理报告可能需要长达 12 个小时。



如果您有疑问,请发送电子邮件至 support@safelyhq.com。

报告人

Safety Report: Sigma 频谱输液泵-由于偏离指定清洁方法而召回,可能会影响输液泵, USA

3年前 source fda.gov

Recall notice

United States

Company name: Baxter International Inc.
Brand name: Sigma Spectrum
Product recalled: Infusion Pumps
Reason of the recall: Deviations from the specified cleaning methods may impair infusion pump
FDA Recall date: October 29, 2020
Recall details: Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may impair infusion pump functionality and performance. Baxter previously communicated this information to customers directly in a Safety Alert on April 1, 2020 and subsequently via an Urgent Device Correction notification on August 28, 2020.

Deviations from the cleaning methods described in product-specific Operator’s Manuals may lead to residue buildup or corrosion of the electrical pins (e.g. depressed pins) on the infusion pump rear case and battery electrical contacts. This could result in notifications that the user should check the battery, or that batteries are not charging or holding their charge. If a device has residue buildup or corrosion, and is running solely on battery power, the pump may shut down without alarming or alerting the user. An undetected or abrupt discontinuation in medication delivery may lead to a delay or interruption of intended treatment. Depending on various factors, including the medication being infused, the volume and rate of the infusion, the route of administration, and patient status and comorbidities, this could result in serious adverse health consequences or death.

To date, Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion. In addition to adhering to the cleaning instructions provided in the Operator’s Manuals for the products listed below, Baxter is instructing customers to assess the rear case electrical pins and battery electrical contacts for residue buildup or corrosion and depressed pins. Baxter is also recommending to have backup devices readily available when infusing critical medications. Additionally, the infusion pumps should be connected to AC power when possible to prevent battery depletion.

Finally, Baxter will be clarifying the Instructions for Use (IFU) to recommend a routine inspection to identify signs of residue buildup, corrosion and depressed pins. Once completed, Baxter will issue a written notification to inform customers of the availability of the updated IFU, which will be accessible in Baxter’s Global Technical E-Service Center: service.baxter.com.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-device-correction-reinforce-important-safety-information-regarding-cleaning

Source: FDA

#medicaldevices #us

最近有趣的报告

F

小指甲刀和纸板包装, Parsons, WV, USA

4周前 reported by user-fqbpm447 细节

我在邮件中收到了一个包裹,上面有我的地址,但没有我的名字。这个名字叫当地的一位女人,我认识她。我在打开之前给她发了消息,看看这是否是她的包裹。不是。然后我打开了包裹,发现它是一个小钉子碎片和一块纸板,仅此而已。

#unorderedpackage #parsons #westvirginia #us

V

诈骗警报, Mississauga, ON, Canada

3周前 reported by user-vbwn7527 细节

我从这家公司订购了一条家庭项链。收到了,但没有收到我订购的商品。我花了 7 块宝石来代表我的孙子孙女。只有 4 颗宝石送来了,但颜色不对。无法与他们取得联系。从 YW 有限公司收到莱尔德路 3495 号 16-17 单元

#scam #onlineshopping #onlinescam #delivery #mississauga #ontario #ca

N
我收到了一个我没有订购的随机包裹。我在网站上查了伙计们的名字,看来其他人也收到了随机的东西。我想知道这是否是骗局以及如何处理商品。加州 Rancho Cucamonga 的 Jerry Yasfbara 我没有订购。这是某种玩具小兵。

#unorderedpackage #delivery #schenectady #newyork #us

G
我一直收到 Slimfit Fusion 发来的我没有订购的货物。它装在一个没有信息的白色信封里,但退货地址是位于加利福尼亚州伯克利市沙特克大道1400号12号套房94709的数据出版社。我没有订阅这个,也不想为此付费。我应该就此联系谁,更重要的是取消订单?

#ketogummiesscam #unorderedpackage #delivery #berkeley #california #us

X
WtMee,也被称为 Torrid 和 Benelumssfitexcencetde
以 88.64 美元的价格从 Torrid 订购了衣服。当被问及为什么大约一个月后还没有收到订单时,回复电子邮件 (wtmee @bjyxpro. com) 指出,由于发货延迟,很难估计送达日期。本应由 UPS/Fedex 配送。几天后,收到了一个装在邮箱里的 USPS 白色塑料袋包裹,里面装有戒指,正如这里发布的其他照片所示。又给公司发了一封电子邮件,说明发生了什么,我预计会退款。将向我的银行/借记卡举报此事;希望能拿回我的钱。

#onlineshopping #scam #delivery #onlinescam #eastarrowhighway #montclair #california #us

过去 30 天