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

Model Number PLUM 360

Device Problems Excess Flow or Over-Infusion (1311); Audible Prompt/Feedback Problem (4020)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

Iv pump was programmed to delivery medication at a rate of 32 ml/hr.Iv medication started in morning.Approximately 55 minutes later, the iv pump alarmed and the iv medication bag was found empty.Anticoagulation medicine was rapidly administered over 1 hour, causing increased bleeding concerns and higher level of monitoring.

• Brand Name: PLUM 360
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 600 n field dr.; lake forest IL 60045
• MDR Report Key: 16795100
• MDR Text Key: 313820139
• Report Number: 16795100
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PLUM 360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male
• Patient Race: White