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.

___________________________________

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.