Recall Z-1272-2022 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1
| Date | Apr 18, 2022 |
| Status | Open, Classified |
| Reason | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001 |
| Root cause | Device Design |
| Action | The firm disseminated an URGENT MEDICAL DEVICE CORRECTION letter on 04/18/2022. The letter provides an overview of eight issues. These issues may result in pump alarm failure, falsely detected alarm failure, termination of active infusion, a state where the smart battery cannot provide its status to the pump, incorrect depleted battery alarm with interrupted infusion, abnormal internal clock behavior, pump run without the ability to terminate infusion via the Stop or Power keys, Program Volume Delivered (PVD) reset to zero, display of a false Rate Below Recommended Minimum for Syringe Size al |
| Quantity | 65093 units |
| Distribution | Worldwide distribution. US nationwide including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN. |
| 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 |