MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 360 INFUSER; PUMP, INFUSION

Catalog Number	30010
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - additional contact number - (b)(6).D4 and h4 - manufacture date is currently not available should this information become available, a follow up report will be provided.It is unknown if the device will be received for evaluation.Without the return of the device a comprehensive evaluation cannot be performed and probable cause cannot be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a plum 360 infusion pump.The customer reported that the pump keeps performing self-check and shutting down.It is unknown if there was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Visual and functional testing: the device was not returned to the service hub, therefore, visual inspection and functional testing was not performed.Unfortunately, the device in question was not returned to the service hub, which precluded us from conducting a visual inspection or functional testing.Review of service and event history: we conducted a review of the device's 12-month service history, which showed no previous occurrences of similar events.Unfortunately, we did not receive any event history from the customer, and thus, we were unable to review the event history/alarm logs.As a result, we could not replicate or confirm the reported issue.

• Brand Name: PLUM 360 INFUSER
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21063156
• Report Number: 9615050-2025-00006
• Device Sequence Number: 8774699
• Product Code: FRN
• UDI-Device Identifier: M3353001004141
• UDI-Public: M3353001004141
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 04/13/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown