Equipment Failure Analysis

设备故障分析
  • 文章类型: Case Reports
    背景:PowerFlow植入式单采静脉端口是一种用于治疗性单采手术的静脉接入装置。在这种情况下,评论文章,我们确定了PowerFlow单采端口与传统端口之间的主要异同。我们还列出了应急部门可以实施的策略,以帮助正确识别港口。
    方法:使用案例评审格式,我们描述了一名33岁女性视神经脊髓炎患者的临床表现,该患者在急诊科接受了急性加重评估。她有使用双侧PowerFlow端口的门诊单采手术史。误认为是传统的港口,使用Huber针头而不是适当的针头导管进入右侧PowerFlow端口。在输注静脉输液时,患者出现疼痛和肿胀。最终,端口出现故障,最终被更换。
    结果:随后的根本原因分析确定了教育和帮助改善港口识别的机会。为此,使用以下至少两种方法实施适当识别PowerFlow端口的策略:(1)在患者的图表中查看植入式单采静脉端口的记录;(2)检查端口识别卡,手镯,或在插入时发出钥匙扣;(3)触诊端口以寻找圆形顶部和中空凹入口点;和(4)使用X射线或荧光透视来识别不透射线的端口标记。
    结论:当具有单采手术史的患者出现植入端口时,应采取措施确保正确的识别和访问。
    BACKGROUND: The PowerFlow implantable apheresis intravenous port is a venous access device for therapeutic apheresis procedures. In this case review article, we identify key similarities and differences between apheresis PowerFlow ports and traditional ports. We also list strategies that emergency departments can implement to aid in correct port identification.
    METHODS: Using a case review format, we describe the clinical presentation of a 33-year-old female with neuromyelitis optica who was evaluated in the emergency department for an acute exacerbation. She had a history of outpatient apheresis procedures that made use of bilateral PowerFlow ports. Mistaken for a conventional port, the right PowerFlow port was accessed with a Huber needle rather than the appropriate catheter-over-needle device. On infusion of intravenous fluids, the patient experienced pain and swelling. Ultimately, the port malfunctioned and was eventually replaced.
    RESULTS: A subsequent root cause analysis identified opportunities for education and aids to improve port identification. To this end, strategies were implemented to appropriately identify the PowerFlow port using at least 2 of the following methods: (1) look in the patient\'s chart for record of an implantable apheresis intravenous port; (2) check the port identification card, bracelet, or keychain issued at insertion; (3) palpate the port to look for the rounded top and hollow concave entry point; and (4) use x-ray or fluoroscopy to identify radiopaque port markers.
    CONCLUSIONS: When a patient with a history of apheresis procedures presents with an implanted port, steps should be taken to ensure correct identification and access.
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  • 文章类型: Journal Article
    重要性:可以分析医疗设备性能和安全数据库,以了解改善患者安全和/或设备设计的模式和新机会。目的:本分析的目的是使用监督机器学习来探索报告的涉及人工耳蜗植入物的不良事件的模式。设计:获得前三个CI制造商的不良事件报告进行分析。使用四种有监督的机器学习算法来预测哪些不良事件描述模式与特定的耳蜗植入物制造商和不良事件类型相对应。设置:美国政府公共数据库。参与者:成人和儿童耳蜗患者。暴露:人工耳蜗的手术放置。主要结果衡量标准:分类预测准确度(%正确预测)。结果:大多数不良事件涉及患者受伤(n=16,736),其次是设备故障(n=10760),死亡(n=16)。随机森林,线性SVC,朴素贝叶斯和逻辑算法能够根据不良事件叙述预测特定CI制造商,平均准确率为74.8%,86.0%,88.5%和88.6%,分别。结论与相关性:使用监督机器学习算法,我们的分类模型能够根据不良事件文字描述的模式,高精度地预测CI制造商和事件类型.
    Importance: Medical device performance and safety databases can be analyzed for patterns and novel opportunities for improving patient safety and/or device design. Objective: The objective of this analysis was to use supervised machine learning to explore patterns in reported adverse events involving cochlear implants. Design: Adverse event reports for the top three CI manufacturers were acquired for the analysis. Four supervised machine learning algorithms were used to predict which adverse event description pattern corresponded with a specific cochlear implant manufacturer and adverse event type. Setting: U.S. government public database. Participants: Adult and pediatric cochlear patients. Exposure: Surgical placement of a cochlear implant. Main Outcome Measure: Classification prediction accuracy (% correct predictions). Results: Most adverse events involved patient injury (n = 16,736), followed by device malfunction (n = 10,760), and death (n = 16). The random forest, linear SVC, naïve Bayes and logistic algorithms were able to predict the specific CI manufacturer based on the adverse event narrative with an average accuracy of 74.8%, 86.0%, 88.5% and 88.6%, respectively. Conclusions & relevance: Using supervised machine learning algorithms, our classification models were able to predict the CI manufacturer and event type with high accuracy based on patterns in adverse event text descriptions.
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  • 文章类型: Journal Article
    There are limited data on the performance of the subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients with a left ventricular assist device (LVAD).
    The purpose of this study was to describe the clinical course and outcomes of patients with both an S-ICD and an LVAD at our institution and via a systematic review of published studies.
    We performed a retrospective cohort study of all patients who underwent LVAD implantation from 2009 to 2019 at Duke University Hospital. We also performed a systematic review of studies involving patients with an S-ICD and LVAD using the PubMed/Embase databases.
    Of 588 patients undergoing LVAD implantation with a preexisting implantable cardioverter-defibrillator, 4 had an S-ICD in situ after LVAD implantation. All 4 patients developed electromagnetic interference (EMI) in the primary/secondary vectors after LVAD implantation, resulting in inappropriate implantable cardioverter-defibrillator shocks in 2 patients. Sensing in the alternate vector was adequate immediately postoperatively in 1 patient. Postoperative undersensing was present in the alternate vector in 3 patients but improved at first outpatient follow-up in 2 patients, allowing tachy therapies to be reenabled. Eight studies involving 27 patients were identified in the systematic review. EMI was common and frequently absent in the alternate vector (6 of 7 patients).
    Undersensing and EMI are common after LVAD implantation in patients with an S-ICD in situ, particularly in the primary and secondary sensing vectors. Undersensing in the alternate vector may improve during follow-up, obviating the need for device revision or extraction.
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  • 文章类型: Case Reports
    我们提供了一份病例报告,记录了一名50岁女性在膝盖下经胫骨截肢后进行的多孔钽(P-Ta)全踝关节置换(TAR)的检索和组织学分析。这种检查完整TAR的难得机会可能有助于更好地了解植入物-骨骼关系,因为它将在原位。
    在这个案例研究中,我们展示了骨向内生长到第一层的P-Ta和有组织的小梁取向,这表明使用经腓骨手术入路在两个组件的底座和导轨上实现了相等的骨负荷。
    We present a case report documenting the retrieval and histological analysis of a porous tantalum (P-Ta) total ankle replacement (TAR) from a 50-year-old woman after a below-knee transtibial amputation. This rare opportunity to examine an intact TAR may help to better understand the implant-bone relationship because it would be in situ.
    In this case study, we demonstrate bone ingrowth to the first layer of the P-Ta and organized trabecular orientation, suggesting that equal bone load was achieved on the base and the rails in both components using a transfibular surgical approach.
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  • 文章类型: Case Reports
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  • 文章类型: Case Reports
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    文章类型: Case Reports
    植入后47年,我们经历了Wada-Cutter假体倾斜盘式瓣膜的植入。患者为53岁女性,因Ebstein异常接受了第一次手术,其中包括三尖瓣置换术(TVR),房间隔缺损(ASD)闭合,6岁时进行后环形缝合。第一次手术后她身体很好没有症状,但是,尽管利尿剂的入院增加,但呼吸困难和全身水肿最近恶化。超声心动图显示三尖瓣重度狭窄,严重的三尖瓣关闭不全,右心房体积增加。阀的倾斜盘几乎是固定的。患者接受了重复TVR。外植的Wada-Cutter阀在整个外壳和圆盘上都被pannus覆盖。瓣膜的结构得以保留,但闭塞盘几乎被血管造影固定,没有扭曲或移位。
    We experienced an explantation of Wada-Cutter prosthetic tilting disk valve of 47 years after implantation. The patient was 53 years old female who underwent the 1st operation for Ebstein\'s anomaly, which included tricuspid valve replacement (TVR), closure of atrial septal defect (ASD) and posterior annulorrhaphy when she was 6 years old. She was doing well after the 1st operation without symptom,but dyspnea and systemic edema worsened recently though increased admission of diuretics. Echocardiography revealed severe tricuspid valve stenosis, severe tricuspid valve insufficiency, and increased right atrium volume. The tilting disk of the valve was almost fixed. The patient underwent repeat TVR. The explanted Wada-Cutter valve was covered by pannus the whole casing and disk. The structure of the valve was preserved but the occlusion disk was almost fixed by pannus formation, not distorted or dislodged.
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  • 文章类型: Case Reports
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  • 文章类型: Case Reports
    METHODS: A 66-year-old active man had undergone revision total knee replacement surgery with a femoral metaphyseal sleeve and a cemented stem in 2013 after loosening of the implant following the primary knee arthroplasty. He was overweight and had a high activity level, and there had been progressive osteolysis surrounding the distal aspect of the femoral sleeve. In 2017, the metaphyseal sleeve had loosened, resulting in corrosion of the threaded taper and catastrophic failure of the implant, with a fracture of the stem at the junction of the sleeve.
    CONCLUSIONS: This unique method of failure in this knee implant highlights a weak point in the design. Clinicians must be aware of the increased likelihood of this type of failure with these implants in patients who have contributory factors.
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  • DOI:
    文章类型: Case Reports
    目的:关于耳蜗植入物在暴露于与水肺和高压氧治疗相关的压力变化期间的安全性的数据有限。没有有关人工耳蜗植入后气压变化对低频听力的影响的数据。该病例报告评估了气压变化对人工耳蜗植入后保留的低频听力的影响。
    方法:这是一例成功进行人工耳蜗植入术并术后保留残余低频听力的患者。
    方法:20个水肺潜水深度为92英尺(3.8个绝对大气压)。
    结果:水肺前后的听力测试显示听力阈值没有变化。耳蜗植入物的内部接收器刺激器不受高达约3.8个绝对大气压的延长和重复压力的影响。患者在潜水期间或之后没有不良的中耳影响,没有内耳气压伤或减压病的证据。
    结论:这是关于潜水后人工耳蜗植入后听力得以维持的第一份报告,并证实了以前的文献表明,暴露于原位耳蜗植入物的压力增加是安全的,而不会对植入物硬件或软件产生不利影响。水肺潜水不仅在人工耳蜗植入时安全,而且在听力残留的患者中也安全。
    OBJECTIVE: There are limited data regarding the safety of cochlear implants during exposure to pressure changes associated with scuba and hyperbaric oxygen therapy. There are no data regarding the effects of barometric pressure changes on preserved low-frequency hearing after cochlear implantation. This case report evaluates the effect of barometric pressure changes on preserved low-frequency hearing after cochlear implantation.
    METHODS: This is a case report of a patient who underwent successful cochlear implantation with postoperative preservation of residual low-frequency hearing.
    METHODS: 20 scuba dives up to depths of 92 feet (3.8 atmospheres absolute).
    RESULTS: Audiometric testing both before and after scuba shows no change in hearing thresholds. The internal receiver-stimulator of the cochlear implant was unaffected by prolonged and repeated pressures up to approximately 3.8 atmospheres absolute. The patient had no adverse middle ear effects during or after the dives, and no evidence of inner ear barotrauma or decompression sickness as a result of the elevated pressures.
    CONCLUSIONS: This is the first report of preserved hearing after cochlear implantation being maintained following scuba diving, and corroborates previous literature showing that exposure to increased pressures with a cochlear implant in situ is safe without adverse effects on the implant hardware or software. Scuba diving appears safe not only with cochlear implants but also in patients with residual hearing.
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