Recall Z-0171-2020 ยท FRN Pump, Infusion
ICU Medical Inc
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
| Date | Oct 22, 2019 (initiated Aug 1, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| Action | On 8/1/2018 a "Urgent Medical Device Correction" letter was mailed to consignees via traceable mailing. The medical device correction letter informed consignees of the following: 1. To reduce the likelihood of the issue occurring at the bedside, you can consider not utilizing the option to "Force Pump to Accept Drug Library During Power Down" when finalizing the CDL with MedNet. In doing so, when powering down the infuser the clinician will have the option to install the CDL or not, based on the clinical situation. 2. ICU Medical will release a software update to correct the issue and will |
| Quantity | 47,152 devices |
| Distribution | US nationwide distribution, and Canada |
| 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 |