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PLUM 360 INFUSION SYSTEM WITH MEDNET (2017-10-19)
- Starting date:
- October 19, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-65066
Affected products
PLUM 360 INFUSION SYSTEM WITH MEDNET
Reason
Issue 1: The user is not able to turn off the pump when a pump in a distal occlusion paused state is exposed to a second "power off then on" malfunction.
Issue 2: When the user accesses the preventive maintenance screen, in service/biomed mode, on Plum 360 v15.10.00.010 devices, with a total delivery time greater than 1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
Affected products
PLUM 360 INFUSION SYSTEM WITH MEDNET
Lot or serial number
SOFTWARE V15.10.00.010
Model or catalog number
30010-XX-YY
Companies
- Manufacturer
-
ICU Medical Inc.
600 NORTH FIELD DRIVE
LAKE FOREST
60045
Illinois
UNITED STATES