MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM 360; 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	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a plum 360 pump where the customer reported that the device shut down while plugged in and infusing fluids to a patient.The battery used was a new csb.There was patient involvement, however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device has been requested to be returned for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, visual inspection and functional testing was not performed.A 12-month service history review could not be conducted due to the absence of a provided serial number.Additionally, as the customer did not provide any event history, a review of the event history/alarm logs could not be conducted.Consequently, we were unable to replicate or confirm the reported complaint.

• Brand Name: UNSPECIFIED PLUM 360
• 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: 21163528
• Report Number: 9615050-2025-00035
• Device Sequence Number: 7831211
• Product Code: FRN
• UDI-Device Identifier: M3353001004141
• UDI-Public: M3353001004141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown