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

Catalog Number	300104206
Medical Device Problem Codes	No Audible Alarm (1019); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter email is (b)(6).The device is not available for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unspecified date and involved a plum 360 infusion pump where it was reported to check battery status, pump does not give alarm when finished (it turns off).The status of the product at the time of the event is "after update".There is unknown patient involvement and unknown adverse event / human harm.
Additional Manufacturer Narrative
Device received on 3/20/2025 additional information: d9.Additional information: e1 - (b)(6).Investigation summary: engineering can confirm the customer¿s claim of the pump turning off and the probable cause is due to the discharge levels being notably lower than for a new battery and/or during infusion and may have malfunctioned and discharged rapidly from level 4 to level 0 in less than 4 hours.Engineering cannot determine if a new physical battery was replace based on the logs.The keypress logs do not show an attempt to perform the corrective action for replacing a battery by performing the biomed [change-battery] actions.The probable cause of the persistent replace battery alarms is due to failing to replace the battery as per the som documentation.Engineering determines the battery should be replaced.Other than this, the pump is operating as per design.Replaced battery, pressed change battery softkey.Pump now doesn't alarm with n56 or n58.Pump passed al pvt and functional test.The old battery was a white text csb battery lot 240421v210.

• Brand Name: PLUM 360 DRIVER REFURB
• 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: 20863417
• Report Number: 9615050-2024-00878
• Device Sequence Number: 18350819
• Product Code: FRN
• UDI-Device Identifier: M3353001004141
• UDI-Public: M3353001004141
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 300104206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2015
• 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