Recall Z-0076-2024 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
| Date | Oct 6, 2023 (initiated Aug 16, 2023) |
| Status | Open, Classified |
| Reason | A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarm |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical sent an URGENT MEDICAL DEVICE CORRECTION notice to its direct consignees on 08/16/2023 by traceable mailing. The notice explained the issue, potential risk to the patient, and requested the following actions be taken: Customer Required Actions 1. Locate all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Ensure all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession have undergone all tes |
| Quantity | 20815 pumps |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP Medex, Inc., Apr 30, 2004 |