Recall Z-0272-2023 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
| Date | Nov 21, 2022 (initiated Oct 10, 2022) |
| Status | Open, Classified |
| Reason | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical notified consignees initially via telephone on 10/10/2022 and followed up with a letter via email on 10/11/2022. The letter was titled "URGENT MEDICAL DEVICE CORRECTION" and instructed consignees to locate all affected pumps and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations, complete and return the attached Response Form to fieldactions@smiths-medical.com, and if Smiths Medical does not contact you to schedule the implementation of the software updates, please contact Smiths Medical Technical Assist |
| Quantity | 422 devices |
| Distribution | US distribution to states of: Indiana, Texas and Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc., Aug 29, 2011 |