Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions

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Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/medical-devices/medical-device-safety/medical-device-recalls" title="Medical Device Recalls"> Medical Device Recalls </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-2" 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"> <h1 class="content-title text-center">Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions</h1> <div class="lcds-toolbar lcds-toolbar--social"> <a href="#subscribe" class="btn btn-sm btn-default header-button-subscribe">Subscribe to Email Updates</a> <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%2Fmedical-devices%2Fmedical-device-recalls%2Fsmiths-medical-asd-inc-recalls-medfusion-model-3500-syringe-pump-due-issues-associated-earlier" 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=Smiths%20Medical%20ASD%20Inc.%20Recalls%20Medfusion%20Model%203500%20Syringe%20Pump%20Due%20to%20Issues%20Associated%20with%20Earlier%20Software%20Versions&url=https://www.fda.gov%2Fmedical-devices%2Fmedical-device-recalls%2Fsmiths-medical-asd-inc-recalls-medfusion-model-3500-syringe-pump-due-issues-associated-earlier" 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%2Fmedical-devices%2Fmedical-device-recalls%2Fsmiths-medical-asd-inc-recalls-medfusion-model-3500-syringe-pump-due-issues-associated-earlier&title=Smiths%20Medical%20ASD%20Inc.%20Recalls%20Medfusion%20Model%203500%20Syringe%20Pump%20Due%20to%20Issues%20Associated%20with%20Earlier%20Software%20Versions&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=Smiths%20Medical%20ASD%20Inc.%20Recalls%20Medfusion%20Model%203500%20Syringe%20Pump%20Due%20to%20Issues%20Associated%20with%20Earlier%20Software%20Versions&body=https://www.fda.gov%2Fmedical-devices%2Fmedical-device-recalls%2Fsmiths-medical-asd-inc-recalls-medfusion-model-3500-syringe-pump-due-issues-associated-earlier" 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"> <p><em>Please be aware, this recall is a correction, not a product removal.</em></p> <h2>Recalled Product</h2> <ul> <li>Product Names: Medfusion syringe pump</li> <li>Product Codes: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=205366">FRN</a></li> <li>Model Numbers: Model 3500 syringe pump</li> <li>Distribution Dates: August 9, 2002 to August 15, 2023</li> <li>Devices Recalled in the U.S.: 85,961</li> <li>Date Initiated by Firm: December 19, 2023</li> </ul> <h2>Device Use</h2> <p>The Medfusion Model 3500 Syringe Infusion Pump is designed for precise control of infusion rates, making it suitable for administering fluids such as blood, lipids, drugs, antibiotics, and therapeutic fluids. It accommodates various delivery routes, including arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral. The pump supports delivery modes like continuous, volume/time, mass, body weight, intermittent, and bolus. It is applicable in critical care, anesthesia, neonatal and pediatric settings, or any healthcare environment where clinician monitoring, or supervision of the syringe infusion pump is feasible.</p> <h2>Reason for Recall</h2> <p>Smiths Medical ASD Inc. is recalling Medfusion model 3500 syringe pump due to issues associated with earlier software versions (before v.6) of the medical pump. Issues associated with earlier software versions of the medical pump include a high-priority alarm for delivery during motor not running, restarting infusion with incorrect parameters, screen lock problems, interruptions in bolus or loading dose delivery, incorrect display of bolus/loading dose information, doses falling below the minimum recommended rate, motor rate errors, incorrect recall of last settings, corrupt configurations, auto lock issues, and problems with the toolbox configuration loading dose time values. If undetected issues are present in the device, there is the potential that the device may fail and result in delay or interruption of therapy, or the device may fail to deliver the therapy per the programmed setting.</p> <p>There have been 1 reported injury and no deaths related to this issue.</p> <h2>Who May be Affected</h2> <ul> <li>Health care providers that use Medfusion Model 3500 Syringe Pumps</li> <li>All patients/persons exposed to the pump, especially vulnerable patients, such as those in the Neonatal Intensive Care unit (NICU) and Cardiac Intensive Care Unit (CICU) who are treated with the Medfusion Model 3500 Syringe Pump</li> </ul> <h2>What to Do</h2> <p>On December 19, 2023, Smiths Medical sent an Urgent Medical Device Correction letter.</p> <p>The letter requested customers to:</p> <ul> <li>Locate all affected pumps and ensure all users of these devices are immediately made aware of this notification and proposed mitigations.</li> <li>Confirm all pumps have the most recent Medfusion software installed.</li> <li>Complete the response form provided and return to <a href="mailto:smithmedical6114@sedgwick.com">smithmedical6114@sedgwick.com</a> within ten days of receipt of this letter.</li> </ul> <h2>Contact Information</h2> <p>Customers in the U.S. with questions about this recall should contact Smiths Medical at 1-(866)-216-8806.</p> <h2>Additional Resources:</h2> <ul> <li><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=205366">Medical Device Recall Database Entry</a></li> </ul> <h2>How do I report a problem?</h2> <p>Health care professionals and consumers may <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home">report adverse reactions or quality problems</a> they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.</p>   </div> <aside class="col-md-2 col-md-push-2" 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Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions | FDA