ICU Medical Recalls Plum 360 Infusion Systems Due to Software Malfunction
ICU Medical is recalling 47,152 Plum 360 Infusion Systems because a software malfunction can cause the device to become inoperable with a blank screen when used with a MedNet Custom Drug Library.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that can become inoperable, posing a risk of harm to patients if infusion therapy is interrupted, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical Inc is recalling 47,152 Plum 360 Infusion Systems with MedNet/Smart Card Plug And Play Module, Model # 30010. The recall involves devices with software versions 15.10.00.010, .011, .012, and 15.11.00.017 when used with an ICU Medical MedNet Custom Drug Library (CDL). The devices were distributed nationwide in the United States and in Canada.
The recall is due to a software malfunction that can occur when a new CDL is downloaded and installed on the infuser. In these cases, the infuser can become inoperable and display a blank screen on the User Interface. The source text does not report any specific injuries, illnesses, or deaths associated with this malfunction.
Healthcare facilities and users should identify affected devices by checking the software version and usage with a MedNet CDL. Users should contact ICU Medical for instructions on how to resolve the issue or obtain a replacement, as the device may fail to function properly during infusion therapy.
The recalled product
- Product
- Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 47,152
Distribution
Distributed nationwide across the United States.
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