MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. UNSPECIFIED PLUM 360 LV INFUSION 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	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date (sometime during week of (b)(6), 2024) and involved an unidentified plum 360 15.2 large volume infusion pump.The customer stated that nursing reported that the pumps were powering off in the middle of an infusion (while patient was received iv fluids) to accept drug library updates.The customer stated that they had the pumps since 2021 and this is the first they have been informed of this.The customer stated that the pumps should accept it without completely powering down.There was patient involvement, and there was no report of medical intervention, no delay in therapy; there was no harm reported as a consequence of this event.
Additional Manufacturer Narrative
Unfortunately, the device in question was not returned to the service hub, which precluded us from conducting a visual inspection or functional testing.An analysis of the device's 12-month service history was not performed, because not serial number was provided.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 LV 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: 20003512
• Report Number: 9615050-2024-00619
• Device Sequence Number: 14671462
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 07/25/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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: IV FLUIDS, MFR UNK
• Patient Sex: Unknown