MAUDE Adverse Event Report: ICU MEDICAL, INC. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

Iv tubing was connected to pt's r ij cvc with sedation, vasopressors, and fentanyl connected.When rn went to disconnect the line to swap out one of the lines the end cracked and came apart.The patient was hemodynamically unstable and became hypotensive while rn tried to troubleshoot the issue.It was able to be resolved, but showed the iv tubing was faulty/malfunctioned.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 17772735
• MDR Text Key: 323713167
• Report Number: 17772735
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2023

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
• Device Model Number: 1468728
• Device Catalogue Number: 1468728
• Device Lot Number: 13493367
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1