MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM 360 INFUSION PUMP; 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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the multiple attempts were requested for the device to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.If additional information becomes available, a supplemental emdr will be submitted at that time.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved an unspecified plum 360 infusion pump.The device reportedly turned off unexpectedly while in an elevator.It was not reported whether or not the pump alarmed before it shut down.The customer is claiming an unspecified sentinel event without any further details.Attempts have been made to obtain further information surrounding any patient details and the event, however, there is no additional information available to provide at this time.

• Brand Name: UNSPECIFIED PLUM 360 INFUSION PUMP
• 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: 21994277
• Report Number: 9615050-2025-00215
• Device Sequence Number: 19955133
• 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: K161469
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: 04/11/2025
• Initial Report FDA Received Date: 05/09/2025
• 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