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62岁老人胸痛到医院就诊手术后不幸身亡术中造影穿孔未及时发现省市两级均鉴定为一级甲等医疗事故5月21日晚，广东新闻频道“今日1线”栏目采访并播出了题目为“62岁老人胸痛到医院就诊手术后不幸身亡”的专题报道，事故经省市两级医学会鉴定认为：术中造影影像明显提示冠脉穿孔的情况下医方术者未尽观察义务，构成一级甲等医疗事故。据新闻报道内容显示，2023年9月27日，患者到广州医科大学附属第二医院心内科就诊，被诊断为“冠状动脉粥样硬化性心脏病”，于当天收入院做冠脉造影术和PCI术，术后不幸死亡。患者死亡后，家属在警察的陪同下完成了病历的封存。在新闻采访中，家属表示：“我们一再强调要求查明真相，但医院无视我们的诉求、冷处理，我们经历了给医院打电话没人接听、给主任发微信不回复的漫长过程，这个过程的煎熬给我们家属带来了无尽的痛苦。我们深知，再拖下去也不会有什么进展，于是我们委托律师开始了漫长的维权。”2024年11月21日，广州市医学会向患者家属发出首次医疗事故技术鉴定书，鉴定书内容显示：鉴定专家组认为，医方在对患者的诊疗过程中存在以下医疗过失行为:据《广州市卫生健康委员会关于XX投诉事项的答复函》及卫生行政执法文书《询问笔录》等资料显示:2023年9月27日17:30左右术者离开手术室向家属告知手术情况，当时手术未结束......;9月27日17:31之前患者未发生特殊情况，9月27日17:31患者出现渗液(考虑发生术中心脏压塞)，立即开始抢救.......鉴定专家组认真查阅造影影像资料获悉，9月27日17:19造影已显示造影剂向心包大量渗漏，提示出现冠脉穿孔。鉴定专家组综合现有的资料分析认为，9月27日17:19，造影已显示造影剂向心包大量渗漏，医方术者对患者术中病情观察存在疏漏，未能及时发现冠脉穿孔并进行处理。鉴定结论为，本例属于一级甲等医疗事故，医方承担次要责任。广医二院对首次鉴定的结果不服，提起了二次鉴定。2025年3月30，广东省医学会向患者家属发出二次鉴定医疗事故技术鉴定书，鉴定书显示：医方存在以下医疗过失:术中未及时发现冠脉穿孔。经认真查阅患者9月27日的造影影像资料，当日17:19造影显示造影剂向心包大量渗漏，提示出现冠脉穿孔，但医方未及时发现，影响了患者的抢救效果。患者家属的代理律师则表示：“17点19分就已经发生了穿孔，造影剂在渗漏，有十多分钟的抢救时间，医方却没有发现，这很明显有过错。”患者家属则表示：“回想起父亲病历里的死亡病例讨论记录，广医二院手术团队认定其‘手术操作规范，整个过程处理及时、得当’，让我不禁费解：如果真的‘手术操作规范，整个过程处理及时、得当’，省市两级医学会又怎么会认定你构成一级甲等医疗事故呢？手术出现重大失误引致患者死亡的后果本就是一件可怕的事情，更可怕的却是医院事后也没有复盘反思，那我父亲这条逝去的生命在医生们的眼中又算得上什么？”据悉，这起经省市两级医学会鉴定为一级甲等医疗事故的案件目前还在处理中。青霉素未做皮试，患者死亡河南一诊所医生被判刑一年4月28日，中国裁判文书网公布了另一起一级甲等医疗事故。根据案由显示，2022年11月17日21时，患者张某因嗓子疼、牙疼、耳朵痒到南阳市某诊所就诊，被告人吴某接诊，诊断为上呼吸道感染，给予输液治疗。输液时，吴某在左氧氟沙星100mL（含量0.2）静滴20mL时，在输液管中加入配制好的青霉素皮试液，观察患者有无不适，想当然以此代替青霉素皮试。后第二瓶输入“生理盐水250mL+青霉素800万+头孢曲松钠4g”10分钟至20分钟左右时，患者张某主诉难受、呛咳，吴某意识到患者对药物过敏，立即换掉液体，给予250mL葡萄糖水静滴，肾上腺素2支肌注，地塞米松10mg肌注，葡萄糖酸钙20mL加盐水100mL静滴，几分钟后患者呼吸、心跳骤停，医方给予心肺复苏并拨打120。22时05分，患者由120救护车转至南阳市中心医院抢救，虽经心肺复苏、心电监护、气管插管、急救药物应用等抢救，患者还是于23时02分宣告临床死亡。患者死亡后，此案被提起诉讼，经河南省医学会鉴定：1、医方给予患者输注青霉素前，未做皮试。在注射用左氧氟沙星中滴入两滴青霉素代替皮试的行为，不符合临床用药规范。2、医方将青霉素与头孢曲松混合应用，违反药物说明书的规定。3、医方对患者的病情诊断为上呼吸道感染，同时应用三种抗生素（其中包含两种β-内酰胺类抗生素）欠妥当。根据患者用药情况，突发病情变化、临床表现及死亡经过等临床资料，专家组综合分析认为：患者符合药物过敏性休克致呼吸循环衰竭死亡。医方过失行为在患者损害后果中起主要作用，故医方应承担主要责任。根据《医疗事故分级标准（试行）》，本案构成一级甲等医疗事故。后经法院另查明，被告人吴某于2019年9月24日取得执业医师资格，未参加2020年5月卧龙区卫健委组织的抗菌药物处方权或者抗菌药物调剂资格的培训和考核。至案发时，没有依法取得“抗菌药物处方权或者抗菌药物调剂资格”。2023年11月29日，吴某与患者家属签署协议，由吴某赔偿丧葬补助金、抚恤金等费用200000元（已支付），家属不再追究吴某任何责任，并对其行为表示谅解。最终，法院判决：综合考虑被告人吴某的犯罪性质、犯罪后果、医疗事故责任、处置违规情况及自首、认罪认罚、赔偿损失并取得谅解等量刑情节，依照《中华人民共和国刑法》、《中华人民共和国刑事诉讼法》，被告人吴某犯医疗事故罪，判处有期徒刑一年，缓刑一年。PCI术中穿孔需及时发现基层诊疗的不规范令人担忧为什么总是动不动就“三素一汤”？近期发生的这两起一级甲等医疗事故给我们带来的教训都很大，其实大概率都可以避免。广东一名心内医生发表评论认为：“造影和PCI术中穿孔，渗漏，是完全可以及时发现的，这是我们心内科偶尔会遇到的情况，识别穿孔不就那些吗？直接证据为：1.冠脉造影可见到造影剂外溢；2.心包内造影剂滞留影；3.术后超声心动图见新发心包积液；4.X线透视下发现心影增大、心脏搏动减弱或消失伴心影外缘透亮带。说到底还是技术不精呀。”查阅资料可知，冠脉穿孔是由于球囊或支架不匹配(扩张导管尺寸过大，尤其是当球囊动脉比>1.2:1或半顺应性球囊持续高压力膨胀时)导致的血管壁破裂引起，或由于导丝在冠脉内无意移动导致。在PCI过程中，冠脉穿孔的发生率低于0.5%，由此引起的心包填塞的发生率约为0.12%，概率还是较低的。冠脉穿孔可以是明显的漏血或局部渗血，表现为造影剂直接漏入心包或局部，也可以是末梢血管不易发现的小的渗漏；少数情况下冠状动脉穿孔在术中未能发现，术后数十分钟至数小时后由于少量持续出血导致心包填塞，及时诊断并积极治疗是降低患者病死率的关键。像上文中的案例，穿孔发现不及时，医生也确实有责任，这真的考验医生的医术。在另一起青霉素未做皮试致死的案例中，我们深为基层医疗的不规范诊疗感到担忧。一看到案例中的信息，笔者就浑身颤抖，一个上呼吸道感染，竟然用了三种抗生素，连β-内酰胺类抗生素都用了，怎么会不出意外呢？只是或早或晚的问题。对此，安徽皖北一名医生就表示：“部分诊所这样处理，效果也立竿见影，老百姓就喜欢这样的处方，由于青霉素易过敏，头孢需皮试，左氧有胃肠道反应，于是，现在他们又选了个有效又折中的方子，用克林霉素或林可霉素，甚至有的诊所能开出极其广谱的亚胺培南！也别管培养什么超级耐药菌了，老百姓说好那就是好，你三天治不好病，你就是庸医！诊所医生开药都特别疯狂。”在患者一味求效果、求立竿见影的现状下，可以想象，基层的不规范用药肯定很难改变，毕竟没效果就没患者，但笔者还是要劝诫基层医生多注意药物配伍的安全性！真的深深担忧，基层的现状就是这样，不验血、不拍片做CT，甚至各种抗原检测试剂也没有，发烧咳嗽无法精准诊断，为了省事求全面，更为了追求效果，三素一汤（抗生素、激素、抗病毒，以及糖和盐）已经成了标配，至于其他的，老百姓不管，老百姓看中的只会是效果。可一旦真的出现了严重问题，像上文中出现了死亡，患者和诊所又都无法承担沉重的代价，说到底这是一个概率问题，医生和患者都心存侥幸，都在赌，赌患者没事，赌自己是命运眷顾的人。撰文 | 阿拉斯加宝编辑 | 阿拉斯加宝● 重磅！63%县医院达到三级水平！成了三级医院，为何还是难留病人？网友：评级上去了，医术改变不大，收费却提高了，很难有吸引力●按掉闹钟多睡会儿or一响就起床？「再睡几分钟让人起床时更清醒，认知表现更佳」vs「频繁打断睡眠、反应更迟钝」，两项研究吵翻了！●热议！取鱼刺花了85元，患者嫌贵，要投诉！网友：我曾在美国拔鱼刺花了1万元，为何这么不知足？鱼刺位置决定收费，医生的价值要被尊重版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」 立刻下载梅斯医学APP！

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Animal & Veterinary Drugs Recipient: Recipient Name Cameron Muir FishMoxFishFlex/Simple Pet Health LLC 520 South 850 East, Ste A1 Lehi , UT 84043 United States info@fishmoxfishflex.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER May 8, 2025 Re: 707196 Dear Cameron Muir: This letter concerns your firm's distribution of animal drug products for use in aquarium fish and birds. In April 2025, the U.S. Food and Drug Administration (FDA) reviewed your website (https://fishmoxfishflex.com/), where you take orders for Fish Mox and Fish Mox Forte Amoxicillin, Bird Zithro Azithromycin, Fish Flex Cephalexin and Fish Flex Forte Cephalexin, Fish Flox Forte Ciprofloxacin, Fish Cin Clindamycin, Fish Doxy Doxycycline, Fish Zole Metronidazole and Fish Zole Forte Metronidazole, Fish Pen Forte Penicillin, and Fish Sulfa Forte Sulfamethoxazole /Trimethoprim. The claims on your website establish that these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. In addition, these animal drugs are misbranded under section 502(o) of the FD&C Act [21 U.S.C. § 352(o)] because they have not been drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA in accordance with sections 510(b) and (j) of the FD&C Act [21 U.S.C. § 360(b), (j)]. As discussed below, introducing or delivering these unapproved and misbranded new animal drugs for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. UNAPPROVED NEW ANIMAL DRUGS Examples of claims observed on your website (https://fishmoxfishflex.com/) that establish the intended use of these products as drugs include, but may not be limited to, the following: Fish • Simple Pet Health Fish Mox and Simple Pet Health Fish Mox Forte (Amoxicillin), 250 mg and 500 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is a broad-spectrum antibiotic that controls gram-positive and some gram-negative bacteria in fish. It works by halting the multiplication of bacteria associated with both fresh and salt water ornamental fish diseases. This fish antibiotic is useful for control of some common bacterial diseases in fish including Dropsy, Fin Rot, Red Pest, and disease caused by bacteria such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” • Simple Pet Health Fish Flex and Simple Pet Health Fish Flex Forte (Cephalexin), 250 mg and 500 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is a broad-spectrum antibiotic that is used in treating a wide variety of non-specific bacterial infections during the most active and multiplying stages of infection. This effective fish antibiotic is helpful with treating a number of pathogenic bacteria associated with ornamental fish diseases.” • Simple Pet Health Fish Flox Forte (Ciprofloxacin), 500 mg tablets. According to your website an “Antibacterial Fish Medication,” “You can help your finned friends feel better and watch your aquarium thrive again with Ciprofloxacin Tablets. This synthetic, board spectrum medication is used treat different strains of bacteria that can plague your fish.” • Simple Pet Health Fish Cin (Clindamycin), 150 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used for the control of some common bacterial fish diseases, such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” • Simple Pet Health Fish Doxy (Doxycycline Hyclate), 100 mg capsules. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used for the control of some common bacterial fish diseases such as Tail Rot, Mouth Rot, Fin Rot, and Septicemia.” • Simple Pet Health Fish Zole and Simple Pet Health Fish Zole Forte (Metronidazole), 250 mg and 500 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Useful to help control some common bacterial diseases in fish such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus). Effective against anaerobic bacteria, a bacteria that only grows where there is no oxygen. Also used to control parasitic diseases such as Cryptocaryon irritans, Ichthyophthirius multifiliis, and Hexamita.” • Simple Pet Health Fish Pen Forte (Penicillin), 500 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used in the control of some common bacterial diseases in fish, including diseases caused by bacteria such as fin and tail rot and Flexibacteria infections.” • Simple Pet Health Fish Sulfa Forte (Sulfamethoxazole/Trimethoprim), 800/160 mg tablets. According to your website an “Antibacterial Fish Medication,” this product “is an antibiotic that exerts a bactericidal action on gram-positive and some gram-negative bacteria in fish. Used in the control of some common bacterial diseases in fish, such as Aeromonas, Pseudomonas, and Mycobacterial (Gill diseases and Chondrococcus).” Birds • Simple Pet Health Bird Zithro (Azithromycin), 250 mg tablets. According to your website an “Antibacterial Bird Medication,” this product “is a fish antibiotic that is used for systemic and local infections in pigeons, pet birds, and exotic birds. This antibiotic is effective against gram-positive bacteria, as well as some gram-negative bacteria, spirochetes, anaerobic bacteria, and other types of microorganisms. Bird ZithroTM is also effective against Chlamydia psittaci in cockatiels. The active ingredient in this medication works by inhibiting the growth of bacteria, which helps to eliminate the bacteria and the infection.” These products are new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because they are for use in nonfood-producing fish and birds, which are minor species as defined by sections 201(nn) and (oo) of the FD&C Act [21 U.S.C. § 321(nn) and (oo)], and are not the subject of a final FDA regulation finding either that the drugs are generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the drug’s labeling, or finding that the exception to the criterion in section 201(v)(1) of the FD&C Act has been met. To be legally marketed, a new animal drug must be the subject of an approved new animal drug application, a conditionally approved new animal drug application, or a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (“index listing”) under section 512, 571, or 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. The FDA approval and index listing processes allow FDA to ensure that there is adequate evidence to demonstrate that new animal drugs are safe, properly manufactured, accurately labeled, and meet the relevant effectiveness standard. The animal drugs named above have not been approved, conditionally approved, or index listed. Animal drugs that lack the required approval or index listing are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a) and 351(a)(5)]. Introduction or delivery for introduction of an adulterated animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. The FDA is particularly concerned about the marketing of these unapproved animal drugs because they contain antimicrobials considered medically important to human health. The growing threat of antimicrobial resistance, especially to drugs that are medically important in human medicine, has prompted FDA to promote judicious use of these drugs in animals. A key part of this effort is ensuring that these medically important antimicrobials are used only under the supervision of a licensed veterinarian. Over-the-counter use of these drugs without veterinary oversight contributes to the development of antimicrobial resistance, posing risks to both human and animal health. MISBRANDED NEW ANIMAL DRUGS Sections 510(b)(1) and (j)(1) of the FD&C Act [21 U.S.C. § 360(b), (j)] require that manufacturers (which includes repackers and relabelers) of drugs, including animal drugs, register their manufacturing establishments with FDA and provide the agency with a list of all the drug products they manufacture. Drugs that are manufactured in unregistered establishments or that have not been listed with FDA are misbranded under section 502(o) of the FD&C Act. None of the animal drugs in this letter are drug listed with FDA, nor have they been manufactured in a facility that is registered with FDA. Accordingly, these animal drugs are misbranded. Introduction or delivery for introduction of a misbranded animal drug into interstate commerce is prohibited under section 301(a) of the FD&C Act. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction. You should be aware that if we take enforcement action against any of the drugs named above or other unapproved/unindexed products you market that contain medically important antimicrobials, we may take action against all of your products that violate the FD&C Act at the same time, including but not limited to enjoining the manufacturing and distribution of all of your unapproved/unindexed products. We have the following comments: 1. You can legally market the products named above if you obtain an index listing, approval, or conditional approval. Information about the processes and requirements for obtaining an index listing and various types of animal drug approval is available on the FDA website at • https://www.fda.gov/animal-veterinary/development-approval-process/minor-useminor-species and • https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications The index listing process was added to the FD&C Act in 2004 as a streamlined alternative process that addresses the challenges of obtaining FDA approval for drugs for minor species (which are any animal species other than horses, cattle, pigs, dogs, cats, chickens, and turkeys). Drugs intended for use in minor species not used for human or animal food are eligible for index listing. Because the above-named products are intended for use in nonfood-producing fish and birds, you may wish to explore the index listing process. The approval process can also be used for drugs for use in these species. 2. Information on establishment registration and drug listing is available on the FDA website at: • https://www.fda.gov/industry/fda-basics-industry/registration-and-listing Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your written response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance, by emailing CVMUnapprovedDrugs@fda.hhs.gov. Sincerely, /S/ Cindy L. Burnsteel, DVM Acting Director, Division of Drug Compliance Office of Surveillance and Compliance Center for Veterinary Medicine Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.