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

Catalog Number	30010
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and was in regard to a general complaint regarding air bubble issues on icu medical infusion pumps, specifically plum 360.The customer reported that the pump had air in the line but continued to infuse during use on a patient.The customer further stated that it seems to only occur when the nurses are doing the ivig infusions where microbubbles appear past the plum cassette.Additional information was received stating that the air seemed to be more of a foam that developed with a specific medication and there was not truly a large air bubble that developed in the line.So, the pump continued to infuse, but that is because the liquid appeared to be more of a foam as it was infused into the patient.There was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device was not returned to the service hub, therefore, visual inspection and functional testing was not performed.Unfortunately, the device in question was not returned to the service hub, which precluded us from conducting a visual inspection or functional testing.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: 20339945
• Report Number: 9615050-2024-00719
• Device Sequence Number: 12732554
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: M3353001004051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161469
• Number of Events Summarized: 1
• Summary Report (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): 05/06/2025

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: 30010
• 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: 09/02/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 05/06/2025
• 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
• Patient Sex: Unknown