Device product
Plum 360 Infusion System, List number 30010.
Z-0101-2018
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 78312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21,461 devices
- Official record key
device-enforcement:Z-0101-2018
Official wording
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.
Code information: All devices with software v15.10.00.010
Distribution pattern: Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
Derived failure modes
-
Unknown
(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.