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

Catalog Number	300100483
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2025 has been used as a placeholder.D4 and h4 the serial#, and manufacture date are unknown.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A medwatch was received regarding an unspecified plum 360 that experienced unexpected shutdown.It was stated that the batteries in the pumps are the csb batteries."one pump has failed while being used on patient with the battery issue." the pump has been sequestered.Thus, there was patient involvement, unknown human harm and unknown delay in therapy reported.Full event description: icumedical 360 plum iv pumps.We purchase 863 iv pumps two months ago and since the go live date we have had 165 have come to biomed with a replaced battery alarm, icu fse.Error code "n56 replace battery" icu medical has replaced 167 batteries but two of the pumps came back with the same problem.A little over 20% of our pumps failed since first purchase.Icu medical assured us before our go live date that battery issue was fixed.The first notification of pump batteries being dead while plugged in was on (b)(6) 2024 and was immediately escalated to icu medical.The batteries in the pumps are the csb batteries.One pump has failed while being used on patient with the battery issue.The pump has been sequestered.
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: 21317504
• Report Number: 9615050-2025-00062
• Device Sequence Number: 8416679
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: M3353001004051
• 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: Administrator/Supervisor
• 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: 300100483
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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