Device product
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Z-0171-2020
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 83480
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,152 devices
- Official record key
device-enforcement:Z-0171-2020
Official wording
Reason: A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
Code information: All Plum 360 Infusers with software versions 15.10.00.010/.011/.012 and 15.11.00.017 when used with an ICU Medical MedNet CDL
Distribution pattern: US nationwide distribution, and Canada
Derived failure modes
-
Device software or design
software malfunction