Product Wiki · Recalls · Health Canada — Medical Devices

PLUM 360 INFUSION SYSTEM WITH MEDNET (2017-10-19) — recall 57573

Health Canada — Medical Devices · Canada · 2017-11-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57573
Date of alert
2017-11-10
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/plum-360-infusion-system-medne

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