MAUDE Adverse Event Report: ICU MEDICAL, INC. PLUM 360; PUMP, INFUSION

Model Number	30010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While infusing iv pump alarmed stating infusion door opened, please close.When door was opened and closed again pump then was frozen.

• Brand Name: PLUM 360
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15111681
• Report Number: 15111681
• Device Sequence Number: 5148607
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: M3353001004051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2022
• Report Date (Section F): 07/25/2022

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 Model Number: 30010
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 07/25/2022