MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 14018-04

Device Problems Failure to Infuse (2340); Obstruction of Flow (2423); Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  malfunction  

Event Description

When attaching secondary tubing to the clave secondary port of primary plum set, the clear part of the clave secondary port is pushed down and will not allow secondary medication to infuse.The iv pump alarms "proximal occlusion line b".This will only resolve by getting new primary plum set tubing.This has happened several times with different lot numbers.

• Brand Name: ICU MEDICAL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 17070606
• MDR Text Key: 316599808
• Report Number: 17070606
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 14018-04
• Device Catalogue Number: 14018-04
• Device Lot Number: 13493394, 13493364, 13474117,
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2023
• Date Report to Manufacturer: 06/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1