MAUDE Adverse Event Report: ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number MC9079

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2020

Event Type  No Answer Provided  

Event Description

In evening was doing air vigilance check on line and noted that the filter was mostly filled with air, no air noted above or below the filter.With the assistance of nurse, accessed port below filter to pull though fluids to evacuate the air and fill the filter with fluid again.Checked the line again in 30 minutes, no air, however 30 minutes later same issue occurred when filter was checked.Air was once again evacuated using port below filter by pulling through fluids.60 minutes later air was again noted.Discussed with nurse, doctor and manager.It was decided to clamp off the line with the air and run the existing medline with flush until new fluids were sent in a syringe - per doctor the ns flush should run at 4 ml since not heparinzed, and that once new fluids arrived fluids would be run on medline tubing with bifuse and a second medline for iv abx.New lines hung after 60 minutes.No issues with blood back up or air in the line in the five hours following.Tubing saved for management to inspect, including air filter.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11064517
• MDR Text Key: 223385002
• Report Number: 11064517
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MC9079
• Device Lot Number: 496148
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA