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

Catalog Number	UNKNOWN
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Event or Problem Description
The event involved an unspecified plum 360 pump where it was noted that it failed due to the battery while infusing medication.The battery was a new csb.There was patient involvement, and no human harm.
Additional Manufacturer Narrative
The device in question was not returned to the service hub; therefore, we were unable to perform a visual inspection or any functional testing to assess the device's performance.A comprehensive review of the device's service history for the past 12 months revealed no previous occurrences of similar events.Unfortunately, we did not receive any event history from the customer, preventing us from reviewing the event history/alarm logs.Consequently, we were unable to replicate or confirm the reported issue.

• Brand Name: UNSPECIFIED PLUM 360 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: 21120992
• Report Number: 9615050-2025-00016
• Device Sequence Number: 7436513
• 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: UNKNOWN
• 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): 03/20/2025

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: UNKNOWN
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown