Recall Z-0101-2018 ยท FRN Pump, Infusion
ICU Medical Inc
Plum 360 Infusion System, List number 30010.
| Date | Oct 30, 2017 |
| Status | Terminated |
| Reason | (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues. |
| Quantity | 21,461 devices |
| Distribution | Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module Hospira, Inc., Mar 28, 2017 |