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FDA Medical Device Recall
Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software VersionsPlease be aware, this recall is a correction, not a product removal.The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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KCER Release Date: February 14, 2024 To: KCER Distribution list- including ESRD Network EDs and QIDs Recalled Product
Device Use The Medfusion Model 4000 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. Reason for Recall Smiths Medical ASD Inc. is recalling Medfusion model 4000 syringe pump due to issues associated with earlier software versions of the medical pump. Issues associated with earlier software versions of the medical pump may affect the alarm system, the pump, the control screen, and other parts of the pump. If undetected issues are present in the device, there is the potential that the device may fail and result in delay or interruption a therapy, or the device may fail to deliver the therapy per the programmed setting. There have been 1 reported injury and no deaths related to this issue.
Who May be Affected
What to Do On December 19, 2023, Smiths Medical sent an Urgent Medical Device Correction letter. The letter requested customers to:
Contact Information Customers in the U.S. with questions about this recall should contact Smiths Medical at 1-(866)-216-8806. Full List of Affected Devices Medfusion syringe pumps, with the following software versions before, may have the following issues:
Additional Resources: How do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
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