MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET

Model Number AM3127

Device Problems Backflow (1064); Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  malfunction  

Event Description

Patient blood pressure acutely dropped.Iv tubing run from pump to patient.Discovered smallbore ext set w/3-port nanoclave manifold was full of blood backing up from central line.One of the connection sites had cracked off.Smallbore ext set w/3-port nanoclave manifold removed from patient and new 4x1 manifold connected with medications.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 16859878
• MDR Text Key: 314485790
• Report Number: 16859878
• Device Sequence Number: 1
• Product Code: FMG
• 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: 04/28/2023

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: AM3127
• Device Catalogue Number: AM3127
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male