Model note · Infusion Pump
ICU Medical Plum 360 Infusion System
The Plum 360 is a cassette based volumetric infusion pump with two lines (A and B) that can run concurrently or as piggyback through one dedicated PlumSet cassette. It is used for parenteral, enteral and epidural therapy and for blood products, and connects by Wi-Fi or Ethernet to ICU Medical MedNet for drug libraries and auto programming. Air and pressure sensing happen in the cassette itself.
The model
Maker, model and type.
- Maker
- ICU Medical, Inc. (formerly Hospira)
- Model
- Plum 360 Infusion System
- Device type
- Infusion Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Delivery rate | Lines A and B 0.1 to 99.9 mL/h in 0.1 steps and 100 to 999 mL/h in 1 mL steps; concurrent minimum 0.5 mL/h per line; 500 mL/h combined maximum | Source |
| Delivery accuracy | Plus or minus 10% at 0.1 to 0.9 mL/h; plus or minus 5% at 1 to 999 mL/h (IEC 60601-2-24 conditions) | Source |
| KVO and VTBI | KVO 1.0 mL/h or the last rate if lower; VTBI 0.1 to 9999 mL; maximum programmable duration 1500 h | Source |
| Air in line thresholds | Distal: 0.1 mL bolus or 0.25 mL cumulative in 4.9 mL; proximal: 0.5 mL bolus or 1.0 mL cumulative | Source |
| Distal pressure limit | Selectable 1 to 15 psi (52 to 776 mmHg), default 6 psi; maximum infusion pressure 20 psi (1034 mmHg) | Source |
| Battery | Sealed lead acid 6 V; about 7 h at 25 mL/h or 4 h at 999 mL/h when new; recharge up to 8 h | Source |
| Power | 100 to 120 VAC or 220 to 240 VAC, 50 to 60 Hz, 50 VA; internal non replaceable fuses | Source |
| Size, weight and life | About 20 x 20 x 15 cm; 4.5 kg with battery; expected service life 10 years | Source |
| Connectivity and nurse call | 802.11 a/b/g/n and Ethernet RJ-45; nurse call 30 VDC, 1 A, factory set normally open | Source |
| Alarm loudness | 40 to 70 dB; high priority 10 beeps, medium 3, low 2 | Source |
| FDA clearance | K141789 (January 2015, Plum 360 with MedNet and CE 3.0); later K161469; product code FRN | Source |
Recalls
Known FDA recalls.
- Z-0482-20252024-10-22
Counterfeit CSB batteries found in Plum 360 and Plum A+ pumps; not validated for use.
FDA record - Z-2447-20242024-05-07
Replacement battery SUB0000864 may lose capacity early (supplier defect).
FDA record - Z-2430-20232023-07-13
Supplier component defect may stop the audible alarm sounding under some conditions.
FDA record - Z-0171-20202018-08-01
New MedNet custom drug library install could leave the pump inoperable with a blank screen.
FDA record - Z-0101-20182017-10-30
Malfunction alarm while paused for distal pressure could leave the pump unable to switch off until the battery ran down or was disconnected.
FDA record - Z-3031-20172017-06-15
Connectivity engine module could disengage, shutting the pump down without alarm.
FDA record - Z-1682-20172016-12-30
Software 15.02: wrong depleted battery alarm, shutdowns and a false E323 after brief mains loss; fixed by software upgrade.
FDA record - Z-1832-20162016-03-25
Proximal occlusion alarms traced to calibration with an out of specification metal cassette.
FDA record
Safety
Safety warnings from the record.
- The pump cannot detect infiltration at the infusion site. Source
- Setting alarm loudness below room noise can stop staff noticing alarms. Source
- Accuracy can be affected by pump height, venous pressure, air in the cassette trap, fluid viscosity and temperature. Source
- Releasing a distal occlusion can push an unintended bolus of up to about 0.67 mL at 25 mL/h, so follow the manual's bolus avoidance steps. Source
- Dispose of the lead acid battery through an authorised recycler. Source
Sources
Where this note comes from.
- ICU Medical Plum 360 System Operating Manual IFU0000342 (rev 03, 2025-05)
- FDA 510(k) K141789 summary, Plum 360 Infusion System with Hospira MedNet
- openFDA recall search, Plum 360
- openFDA MAUDE problem counts, Plum 360 brand
Not covered: Only a selection of the manual's N and E alarm codes is listed; the technical service manual (calibration, part numbers) was not reviewed. The E325 pairing was read from a two column table layout and should be confirmed. Recall records were read through openFDA. MAUDE counts include summary reporting and are trends only.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Infusion Pump