NATICK, MA / ACCESSWIRE / March 20, 2024 / InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems dated May 2019 to August 2023.

马萨诸塞州NATICK/ACCESSWIRE/2024年3月20日/InfuTronix，LLC宣布自愿召回Nimbus非卧床输液泵系统，包括Nimbus II PainPro、Nimbus II Flex、Nimbus II Plus、Nimbus II EpiD和Nimbus II EMS，原因是2019年5月至2023年8月，与Nimbus输液泵系统相关的客户投诉数量很高（3698）。

Evaluation of complaint data has identified several potential product issues:.

对投诉数据的评估发现了几个潜在的产品问题：。

Nimbus Pump System

Nimbus泵系统

Battery Power may potentially affect the performance of the pump by causing an immediate power off event.

电池电量可能会导致立即断电事件，从而潜在地影响泵的性能。

Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.

如上游阻塞警报所述，当给药组近端的流动受阻时，会发生上游阻塞。

System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.

系统错误，如系统错误警报所示，导致泵暂停输液。

Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.

药品从某些给药设置的粘合点流出，这可能会导致药品从设备中泄漏。

Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.

流速（高或低），可能导致泵注入不准确的药物输送。

Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.

泵壳的设计可能会随着时间的推移对负责管理装置接合的壳体的某些区域造成损坏，从而导致错误的阻塞和流量不准确。

These product issues were identified through the InfuTronix post-market surveillance system and evaluated through the InfuTronix Corrective Action/Preventive Action (CAPA) system. InfuTronix has determined that the best corrective and preventive action to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system.

这些产品问题是通过InfuTronix上市后监测系统确定的，并通过InfuTronix纠正措施/预防措施（CAPA）系统进行评估。InfuTronix已经确定，解决已确定的产品问题和潜在结果的最佳纠正和预防措施是重新设计Nimbus输液泵系统。

The redesign of the system will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required.

该系统的重新设计将使InfuTronix能够改进产品的几个方面，包括机械、电子、软件和外壳设计以及管理集的各个方面。鉴于预期的设计改进数量以及对设计，验证和验证的广泛要求，InfuTronix认为可能需要新的上市前通知和FDA的批准。

As such, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance(s) is obtained..

因此，InfuTronix正在寻求将该系统从市场上删除，同时正在进行这些改进和设计更改，并获得新的许可。。

A health hazard evaluation (HHE) was performed by an independent physician to evaluate routine post-market complaint failure modes associated with the Nimbus family of infusion pumps. The HHE determined that the common device failure modes pose a low risk to users.

一名独立医生进行了健康危害评估（HHE），以评估与Nimbus输液泵系列相关的常规上市后投诉故障模式。HHE确定常见的设备故障模式对用户的风险较低。

The Nimbus Infusion Pump system has been distributed throughout the United States since October 17, 2014 until February 21, 2024. It has never been distributed internationally.

自2014年10月17日至2024年2月21日，Nimbus输液泵系统已在美国各地销售。它从未在国际上分发过。

Affected devices have the following Unique Device Identification numbers associated with them:

受影响的设备具有以下与之关联的唯一设备标识号：

Nimbus Ambulatory Infusion Pump 00817170020000

Nimbus流动输液泵00817170020000

Nimbus II PainPRO 00817170020086

Nimbus II PainPRO 008717000086

Nimbus II Flex 00817170020093

Nimbus II Flex 00817170020093

Nimbus II Plus 00817170020161

Nimbus II Plus 00817170020161

Nimbus II EpiD 00817170020376

Nimbus II EpiD 00817170020376

Nimbus II EMS 00817170020109

Nimbus II EMS 00817170020109

Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

在拆卸过程中，用户可以继续使用Nimbus输液泵系统和相关的输液器。用户应注意指示泵潜在问题的标志（如何识别设备可能出现故障）：

Battery - The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.

电池-输液泵将变黑（故障保护）。用户将看到泵已关闭。此外，LED屏幕可能在故障前闪烁，表明潜在的电池问题。

Upstream Occlusion - Auditory and visual occlusion alarm alerts the user of the occlusion.

上游遮挡-听觉和视觉遮挡警报提醒用户遮挡。

System Error - Auditory and visual system error alarm will alert the user.

系统错误-听觉和视觉系统错误警报将提醒用户。

Drug Product Egress - The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.

药品出口-用户可能会注意到泵袋或输液器中的药物泄漏或感觉药品潮湿。

Flow Rate (high/low) - Auditory and visual occlusion alarm for low flow will alert the user of occlusion. The user will notice residual volume remaining at the end of therapy. High flow rate may be associated with shortened infusion times.

流量（高/低）-低流量的听觉和视觉遮挡警报将提醒用户遮挡。用户将注意到治疗结束时剩余的体积。高流速可能与缩短输注时间有关。

Pump Housing Damage - The user may notice broken latches, hinges, or cracks in the housing and/or user may notice that the device is difficult to assemble prior to use.

泵壳体损坏-用户可能会注意到壳体中的闩锁、铰链或裂纹断裂，和/或用户可能会注意到设备在使用前难以组装。

Infutronix has already notified customers with a letter that details the products impacted, reason for the voluntary removal, risk to health assessment, how to recognize the device may fail and actions to be taken by the customer/user.

Infutronix已经向客户发出了一封信，详细说明了受影响的产品、自愿移除的原因、健康风险评估、如何识别设备可能出现故障以及客户/用户应采取的行动。

The continued use of the Nimbus Infusion Pump system and associated infusion sets is safe during this removal process. Users should be aware of the signs indicating a potential issue with the pump as described above, 'How to recognize that a device may fail'.

在拆卸过程中，继续使用Nimbus输液泵系统和相关输液器是安全的。用户应注意上述指示泵潜在问题的标志，“如何识别设备可能出现故障”。

As with any use, health care providers (HCPs) should read the Instructions for Use (IFU) and follow those closely to ensure proper performance of the pump with its associated accessory set. Further, HCPs should educate patients on proper use of the pump and accessories, and potential operational concerns..

与任何使用一样，医疗保健提供者（HCP）应阅读使用说明（IFU），并严格遵循这些说明，以确保泵及其相关附件的正确性能。此外，医护人员应教育患者正确使用泵和配件，以及潜在的操作问题。。

As a reminder to HCPs,

提醒HCP，

When replacing batteries, only new batteries should be used. Care should be taken to ensure that old and new batteries are not confused when completing the replacement. When resetting the battery state, HCPs are encouraged to pay close attention to the device indicator lights and LED screen indicating battery life..

更换电池时，只能使用新电池。在完成更换时，应注意确保新旧电池不会混淆。重置电池状态时，鼓励HCP密切注意设备指示灯和指示电池寿命的LED屏幕。。

HCPs should take care to clear an occlusion alarm properly. The battery should not be cycled (turned on/off) to clear the occlusion alarm. If the occlusion alarm cannot be cleared, a new pump should be used. Patients should be educated that silencing the alarm does not clear the occlusion.

医护人员应注意正确清除遮挡警报。不应循环（打开/关闭）电池以清除遮挡警报。如果无法清除阻塞警报，则应使用新泵。应该教育患者沉默警报并不能清除阻塞。

Due to the potential ambulatory use of the pump, patients may carry the drug product dispensing pouch in a carrying pack. Patients should be educated that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause the device to malfunction.

由于该泵可能在门诊使用，患者可能会在携带包中携带药品配药袋。应该教育患者，阻碍管道设置或对设备施加压力（靠着它，坐在上面）可能会导致设备发生故障。

HCPs are encouraged to educate patients on potential drug leakage and establish appropriate containment protocols for users to follow.

鼓励医务人员对患者进行潜在药物泄漏的教育，并建立适当的遏制方案供用户遵循。

HCPs should ensure users are educated to recognize audio and visual alarms and inspect their device for damage. Any difficulties or abnormalities noted with the pump or accessories should result in immediate discontinued use of the pump and notification to the HCP.

HCP应确保教育用户识别音频和视频警报，并检查其设备是否损坏。如果发现泵或附件有任何困难或异常，应立即停止使用泵，并通知HCP。

Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service at Customerservice@intuvie.com, where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning both the Nimbus Infusion Pumps and associated infusion sets.

拥有Nimbus输液泵和相关输液器的InfuTronix客户应联系InfuTronix客户服务Customerservice@intuvie.com，他们将被指示返回Nimbus输液泵和相关输液器所需遵循的退回材料授权（RMA）流程。

Customers who purchase the Nimbus Infusion Pump and/or associated infusion sets from a distributor should contact their distributor directly and receive instructions on the RMA process to be followed..

从经销商处购买Nimbus输液泵和/或相关输液器的客户应直接与其经销商联系，并接受有关RMA流程的说明。。

As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient's needs, based on their medical expertise, at the earliest possible opportunity.

由于该设备在2024年6月20日后将不可用或不受支持，InfuTronix鼓励医疗保健提供者根据他们的医学专业知识，尽早寻求适合患者需求的替代药物输注方法。

InfuTronix is removing the Nimbus Infusion Pump Systems from the market. The products will no longer be supported by InfuTronix for either Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. To return Nimbus products customers should follow the instructions provided in the Medical Device Removal letter that was sent by InfuTronix, contact InfuTronix customer service or their local distributor..

InfuTronix正在从市场上删除Nimbus输液泵系统。2024年6月20日以后，这些产品将不再由InfuTronix支持用于Nimbus输液泵或相关输液器。要退回Nimbus产品，客户应遵循InfuTronix发送的医疗器械拆除信中提供的说明，联系InfuTronix客户服务或其当地经销商。。

For further inquiries, please contact InfuTronix Customerservice@intuvie.com or call 508-650-2008, Option 8, Monday through Friday between the hours of 9:30AM and 5:00PM, Eastern Time (ET).

如需进一步查询，请联系InfuTronixCustomerservice@intuvie.com或者在东部时间（ET）周一至周五上午9:30至下午5:00之间致电508-650-2008，选项8。

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

使用本产品遇到的不良反应或质量问题可通过在线、定期邮件或传真向FDA的MedWatch不良事件报告程序报告。

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

在线填写并提交报告：www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

普通邮件或传真：下载表格www.fda.gov/MedWatch/getforms.htm或致电1-800-332-1088索取报告表格，然后填写并返回预先写好地址的表格上的地址，或通过传真提交至1-800-fda-0178

SOURCE: InfuTronix

来源：InfuTronix

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