Events

Recall of Plum 360 Infusion System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ICU Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78312
  • Event Risk Class
    Class 2
  • Event Number
    Z-0101-2018
  • Event Initiated Date
    2017-10-30
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159159
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • 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.
  • Action
    The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.

Device

Plum 360 Infusion System
  • Model / Serial
    All devices with software v15.10.00.010
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
  • Product Description
    Plum 360 Infusion System, List number 30010.
  • Manufacturer
    ICU Medical Inc

Manufacturer

ICU Medical Inc
  • Manufacturer Address
    ICU Medical Inc, 600 N Field Dr, Lake Forest IL 60045-4835
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA