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

Catalog Number	30010
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An event involving a plum 360 reported that the intravenous (iv) pump was alarming for proximal air while infusing norepinephrine.Back priming was done, and no air bubbles were seen in the syringe.However, after restarting the pump, the alarm for air persisted, and the process was repeated multiple times with no air detected each time.Due to the interruptions in the norepinephrine infusion, the patient's blood pressure dropped to 72/54, then 59/51, requiring a registered nurse (rn) to administer 200 mcg of iv phenylephrine.The iv line and pump were replaced, and a new infusion was started with no further issues.There was patient involvement and patient harm reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as serial number is unknown.Additional contact information (b)(6), l4k 5r8, canada.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

• Brand Name: PLUM 360 INFUSER
• 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: 24438715
• Report Number: 9615050-2026-00128
• Device Sequence Number: 16007579
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: M3353001004051
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/21/2026
• 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: 200 MCG OF IV PHENYLEPHRINE, UNK MFR.; IV LINE, ICU MED.; NOREPINEPHRINE, UNK MFR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown