. 600 N. Field Drive Lake Forest, IL 60045 (224) 212 2000 www.icumed.com 15 June 2017 URGENT: MEDICAL DEVICE CORRECTION Plum 360 Infusion System List Number: 30010 Dear Valued Plum 360 Infusion System Customers: Director of Risk Management Director of Nursing Director of Biomedical Engineering ICU Medical is issuing this letter to notify you of a potential issue with the Plum 360 Infusion System. This product notification details the issue and the required steps for you to perform. Issue: ICU Medical has identified a potential for the Connectivity Engine (CE) Module to disengage from the main chassis. In a rare situation, this could lead the Plum 360 Infuser to power down without an alarm notification resulting in a delay of either initiation of a therapy or interruption of an active infusion. To date, ICU Medical has not received any reports of serious injury or death associated with this issue. Potential Risk: If the CE Module were to disengage, the infuser powers down without an alarm. This could lead to a delay in initiating a therapy or interruption of an active infusion delivery. In rare circumstances, these conditions could lead to serious adverse health consequences related to changes in a patient s vital signs. Affected Product: All Plum 360 Infusers manufactured between 29 April 2015 and 25 October 2016 and initially distributed before 01 May 2017 are impacted by this issue. See attachment for serial numbers of affected infusers. Required Actions for Users: Please inspect the affected Plum 360 Infusers at your facility according to the following instructions (refer to serial numbers in Attachment titled URGENT: MEDICAL DEVICE CORRECTION, Plum 360 Infusion System, List Number 30010, Attachment: Affected Serial Numbers ): 1. Verify that the infuser is working. Power the infuser ON by pressing the ON/OFF button and verify that the LCD screen is turned on. Page 1 of 3 MA1706 01 (2)
. 600 N. Field Drive Lake Forest, IL 60045 (224) 212 2000 www.icumed.com 2. With the infuser and display ON, rest the infuser on a rigid flat surface with the CE Module facing you. 3. Test for a loose CE Module by holding the infuser down with one hand and pulling firmly on the CE Module. 4. If a loose CE module or blank display is observed, remove the infuser from service. Record the S/N and contact the ICU Medical Technical Service Support Center at 1 800 241 4002, option 4. Otherwise, return the infuser to clinical service. During normal use, if the Plum 360 Infuser powers down without an alarm notification, please use another Plum 360 Infuser for infusion or consider use of alternative infusion methods based on the clinical situation and contact ICU Medical Global Complaint Management at the number in the table below. Follow up Actions by ICU Medical: ICU Medical has identified the root cause of this issue. All affected Plum 360 infusers will be inspected and the chassis will be replaced as required. ICU Medical will contact you, when replacement parts are available, to initiate the scheduling process for the correction. For further inquiries, please contact ICU Medical using the information provided below. ICU Medical Contact Contact Information Areas of Support Global Complaint Management 1 800 441 4100 (M F, 8am 5pm CT) (ProductComplaintsPP@icumed.com) To report adverse events or product complaints Technical Support Center 1 800 241 4002, option 4 Additional information or (M F, 8am 6pm CT) technical assistance (supportservices@pfizer.com) The U.S. Food and Drug Administration (FDA) has been notified of this action. Page 2 of 3 MA1706 01 (2)
Plum 360 Infusion System Main Chassis Assembly Urgent Medical Device Correction Notification Frequently Asked Questions ICU Medical is issuing a medical device correction notification informing affected customers about a potential risk associated with a possibility for the Connectivity Engine (CE) Module to disengage. ICU Medical is notifying each affected customer and authorized distributors of this issue. ICU Medical does not require that customers return their Infusers. If your Plum 360 Infuser powers down during infusion or during set up, please contact ICU Medical Global Complaint Management at 1 800 441 4100 (M F, 8am 5pm CT) or ProductComplaintsPP@icumed.com. 1. Q What is the issue? The metal inserts used to secure the CE Module to the main chassis may have been assembled incorrectly by the chassis supplier. This may lead to the CE Module potentially disengaging from its connector. 2. Q What is the potential risk? If both metal inserts are not properly assembled to the chassis securing the CE Module, the CE Module may potentially disengage which may lead the system to power down without alarm resulting in an interruption of infusion or delay of infusion setup. If this event were to occur, clinicians will need to utilize another Plum 360 Infuser to continue infusion or alternative infusion methods as appropriate for the clinical situation. 3. Q What devices are affected? Plum 360 Infusers manufactured between 29 April 2015 and 25 October 2016. 4. Q How can a customer identify which devices need corrective action? Impacted customers will receive a list of affected serial numbers requiring inspection and potential corrective action. 5. Q Has there been any patient harm related to this risk? No. To date, there have been no reports of patient harm or medical interventions due to this issue. 6. Q What action is ICU Medical taking? ICU Medical is notifying affected customers via the attached letter. ICU Medical will also contact customers to schedule chassis inspections and required replacements for affected Plum 360 infusers. Page 1 of 4 MA1706 01 (2)
7. Q Can Plum 360 Infusers at my facility continue to be used? Please verify the infusers on the list of affected serial numbers included with the Urgent Medical Device Correction notification are at your facility. For the affected infusers, please perform the following inspection to determine if your Plum 360 infusers can remain in clinical service: 1. Verify that the infuser is working. Power the infuser ON by pressing the ON/OFF button and verify that the LCD screen is turned on. 2. With the infuser and display ON, rest the infuser on a rigid flat surface with the CE Module facing you. 3. Test for a loose CE Module by holding the infuser down with one hand and pulling firmly on the CE Module. 4. If a loose CE module or blank display is observed, remove the infuser from service. Record the S/N and contact ICU Medical Technical Support Center at 1 800 241 4002, option 4. Otherwise, return the infuser to clinical service. 8. Q How is the customer communication sent? The notifications are being sent to the Director of Risk Management, Director of Nursing and Director of Biomedical Engineering of your facility. Only affected customers will receive the notification. Each affected customer and distributor will receive via courier a Letter, FAQs, Summary of Affected Infusers and Response Card. 9. Q Is the information available online? Yes. The letter, FAQs, and list of affected infusers can be found on ICU Medical s website at http://www.icumed.com/support/customer communications.aspx Page 2 of 4 MA1706 01 (2)
10. Q Is this a voluntary action? Yes. ICU Medical is voluntarily taking this action. 11. Q What is the corrective action? All infusers will be inspected and in cases where the CE Module is not firmly seated, the chassis will be replaced. 12. Q Can a customer perform the corrective action? No. Customers can only inspect all Plum 360 infusers to ensure the CE Module is firmly seated. ICU Medical cautions customers to not open the infuser for visual inspection as the process of opening the infuser may inadvertently impact the securement of the CE Module. This should be left for ICU Medical representatives. Replacement of chassis must be performed by ICU Medical. 13. Q Should I return affected infusers for remediation? No. It is not necessary to return infusers to replace the main chassis. Visual inspection of the affected infusers and replacement of the chassis can be completed in the field; however, replacement of the chassis must be performed by ICU Medical. 14. Q I only have a small number of affected infusers. Should I return affected infusers for remediation? You may return infusers for remediation if you prefer. ICU Medical can discuss this option with you when calling to discuss scheduling. Alternatively, to make arrangements for returns for repair, please contact ICU Medical s Technical Support Center at 1 800 241 4002 to obtain a Returned Goods Authorization. For a larger number of affected infusers (10 or more) ICU Medical recommends we schedule an onsite repair. 15. Q Who should I contact if I have additional questions? Please contact the ICU Medical Technical Support Center directly at 1 800 241 4002. 16. Q Will ICU Medical provide loaner infusers? No. ICU Medical will not be offering loaner infusers. 17. Q Has FDA been notified? Yes. 18. Q Can the hospital biomed technicians perform the chassis replacement? No. 19. Q How long will it take to perform the corrective action? Typical inspection and replacement of chassis is expected to take about 1 hour per infuser. Depending on your facility s infuser population and other variables ICU Medical will define a team size for your location. We will be able to typically process about 8 infusers per day per service technician at your facility subject to other variables. 20. Q Does this issue impact any shipments of new Plum 360 Infusion Systems? No. The chassis assembly issue was corrected. There is no impact on Plum 360 shipments. Page 3 of 4 MA1706 01 (2)
21. Q Can ICU Medical perform additional services for the infusers while onsite? Yes; however, since this notification pertains to potential for risk, ICU Medical will focus on completing actions to mitigate the potential risk associated with this and/or any other open corrective actions. 22. Q Where can I find more information? ICU Medical Contact Contact Information Areas of Support ICU Medical Global Complaint Management 1 800 441 4100 (M F, 8am 5pm CT) (ProductComplaintsPP@icumed.com) To report adverse events or product complaints ICU Medical Technical Support Center 1 800 241 4002, option 4 (M F, 8am 6pm CT) (supportservices@pfizer.com) Additional information or technical assistance Page 4 of 4 MA1706 01 (2)