Cl II Plum 360 Infusion System

Company:ICU Medical Inc
Date of Enforcement Report 11/22/2017
Class lI:

PRODUCT

Plum 360 Infusion System, List number 30010.
Recall Number Z-0101-2018

REASON
(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.

RECALLING FIRM/MANUFACTURER
ICU Medical Inc., Lake Forest, IL on 10/30/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
21,461 devices

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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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