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	06/06/2024
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 icu medical plum 360 pump where a patient had a cardizem drip infusing, and the pump turned off without any notification.The pump off but continued to alarm with no ability to shut off, no warning sign of this occurring.The patient is a 44-year-old, white, non-hispanic, female weighing 61kg.There was patient involvement and unknown human harm.
Additional Manufacturer Narrative
The device was not available for complaint investigation and was not returned to the service hub for evaluation.We were unable to replicate or verify the reported issue.Corrected information can be found in e3 - initial reporter occupation.Additional information can be found in g4 - pma/510(k) # and g2.

• 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: 21121024
• Report Number: 9615050-2025-00017
• Device Sequence Number: 15636593
• Product Code: FRN
• UDI-Device Identifier: M3353001004141
• UDI-Public: M3353001004141
• Combination Product (Y/N): N
• 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: Other,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 03/28/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARDIZEM, MFR UNK
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White