Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)

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Withdrawals, & Safety Alerts"> Recalls, Market Withdrawals, & Safety Alerts </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-7" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <p class="content-type-label text-center">COMPANY ANNOUNCEMENT</p> <h1 class="content-title text-center">Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)</h1> <div class="alert alert-danger text-center col-xs-12" id="disclaimer"> <p>When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.</p> <a class="btn btn-default" href="#recall-announcement">Read Announcement</a> </div> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbaxter-issues-urgent-device-correction-reinforce-important-safety-information-regarding-cleaning" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Baxter%20Issues%20Urgent%20Device%20Correction%20to%20Reinforce%20Important%20Safety%20Information%20Regarding%20Cleaning%20Practices%20of%20all%20Sigma%20Spectrum%20Infusion%20Pumps%20%28V6%2C%20V8%20and%20IQ%29&url=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbaxter-issues-urgent-device-correction-reinforce-important-safety-information-regarding-cleaning" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbaxter-issues-urgent-device-correction-reinforce-important-safety-information-regarding-cleaning&title=Baxter%20Issues%20Urgent%20Device%20Correction%20to%20Reinforce%20Important%20Safety%20Information%20Regarding%20Cleaning%20Practices%20of%20all%20Sigma%20Spectrum%20Infusion%20Pumps%20%28V6%2C%20V8%20and%20IQ%29&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Baxter%20Issues%20Urgent%20Device%20Correction%20to%20Reinforce%20Important%20Safety%20Information%20Regarding%20Cleaning%20Practices%20of%20all%20Sigma%20Spectrum%20Infusion%20Pumps%20%28V6%2C%20V8%20and%20IQ%29&body=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbaxter-issues-urgent-device-correction-reinforce-important-safety-information-regarding-cleaning" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <h2>Summary</h2> <div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">Company Announcement Date:</dt> <dd class="cell-2_1"><time datetime="2020-10-28T14:19:00Z">October 28, 2020</time> </dd> <dt class="cell-1_2">FDA Publish Date:</dt> <dd class="cell-2_2"><time datetime="2020-10-29T04:00:00Z">October 29, 2020</time> </dd> <dt class="cell-1_3">Product Type:</dt> <dd class="cell-2_3">Medical Devices </dd> <dt class="cell-1_4">Reason for Announcement:</dt> <dd class="cell-2_4"> <div class="field field--name-field-recall-reason-description field--type-string field--label-above"> <div class="field--label">Recall Reason Description</div> <div class="field--item">Deviations from the specified cleaning methods may impair infusion pump </div> </div> </dd> <dt class="cell-1_5">Company Name:</dt> <dd class="cell-2_5">Baxter International Inc.</dd> <dt class="cell-1_6">Brand Name:</dt> <dd class="cell-2_6"> <div class="field field--name-field-brand-name field--type-entity-reference field--label-inline"> <div class="field--label">Brand Name(s)</div> <div class="field--items"> <div class="field--item">Sigma Spectrum</div> </div> </div> </dd> <dt class="cell-1_7">Product Description:</dt> <dd class="cell-2_7"> <div class="field field--name-field-product-description field--type-string field--label-above"> <div class="field--label">Product Description</div> <div class="field--items"> <div class="field--item">Infusion Pumps</div> </div> </div> </dd> </dl> </div> <hr> <h2 id="recall-announcement">Company Announcement</h2> <p>Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all <strong>Spectrum</strong> 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 <a href="https://www.baxter.com/our-products/important-product-updates">previously communicated</a> 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.</p> <p>Deviations from the cleaning methods described in product-specific Operator鈥檚 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. <strong>To date, Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion.</strong></p> <p>In addition to adhering to the cleaning instructions provided in the Operator鈥檚 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鈥檚 Global Technical E-Service Center: https://service.baxter.com.</p> <div class="inset-column"> <table class="table table-bordered table-striped table-condensed"> <thead> <tr> <th scope="col"> <p align="center"><strong>Product Code </strong></p> </th> <th scope="col"> <p align="center"><strong>Product Description </strong></p> </th> <th scope="col"> <p align="center"><strong>Serial Number </strong></p> </th> </tr> </thead> <tbody> <tr> <td class="text-align-center">35700BAX</td> <td class="text-align-center" rowspan="2">SIGMA SPECTRUM Infusion System<br> (V6 Platform)</td> <td class="text-align-center" rowspan="4">All</td> </tr> <tr> <td class="text-align-center">35700ABB</td> </tr> <tr> <td class="text-align-center">35700BAX2</td> <td class="text-align-center">SIGMA SPECTRUM Infusion System<br> (V8 Platform)</td> </tr> <tr> <td class="text-align-center">3570009</td> <td class="text-align-center">Spectrum IQ Infusion System with Dose<br> IQ Safety Software</td> </tr> </tbody> </table> </div> <p>Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time. Any adverse events experienced with the use of these products may be reported using one of the following options:</p> <ul type="disc"> <li>Calling Baxter Product Surveillance at 800-437-5176 Monday through Friday between 8 a.m. and 5 p.m. Central Time</li> <li>Emailing Baxter at: <a href="mailto:corporate_product_complaints_round_lake@baxter.com">corporate_product_complaints_round_lake@baxter.com</a></li> <li>Complete and submit the report <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="30cfb1be-3244-4fd7-a804-9647e3551562" href="/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda" title="Reporting Serious Problems to FDA">Online</a></li> <li>Regular Mail or Fax: Download form 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</li> </ul> <p>Baxter is voluntarily issuing this Urgent Device Correction with the knowledge of the U.S. Food and Drug Administration.</p> <p><strong>About Baxter</strong></p> <p>Every day, millions of patients and caregivers rely on Baxter鈥檚 leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we鈥檝e been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter鈥檚 employees worldwide are now building upon the company鈥檚 rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit <a href="http://www.baxter.com/">www.baxter.com</a> and follow us on <u><a href="https://twitter.com/baxter_intl?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor">Twitter</a></u>, <u><a href="https://www.linkedin.com/company/baxter-healthcare/">LinkedIn</a></u> and <u><a href="https://www.facebook.com/BaxterInternationalInc/">Facebook</a></u>.</p> <div class="inset-column"> <hr> <h2>Company Contact Information</h2> <div class="row"> <div class="col-xs-12 col-md-6"> <dl> <dt>Consumers:</dt> <dd>Baxter Technical Assistance</dd> <dd><span class="fa fa-phone" aria-hidden="true"></span> 800-356-3454, Choose Option 1</dd> </dl> </div> <div class="col-xs-12 col-md-6"> <dl> <dt>Media:</dt> <dd>Bess Featherstone </dd> <dd><span class="fa fa-phone" aria-hidden="true"></span> 224-948-5353</dd> <dd><span class="fa fa-envelope" aria-hidden="true"></span><a href="mailto:media@baxter.com"> media@baxter.com</a></dd> </dl> </div> </div> </div>   </div> <aside class="col-md-2 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Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ) | FDA