—#159159

Product

Plum 360 Infusion System, List number 30010.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K161469
Affected lot / code info: All devices with software v15.10.00.010

Why it was recalled

(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 (FDA determination)

Under Investigation by firm

Action the firm took

The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.

Recalling firm

Firm: ICU Medical Inc
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.

Timeline

Recall initiated: 2017-10-30
Terminated: 2019-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159159. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.