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

Model Number FILTER: MC9079, BIFUSE: MC33129

Device Problem Backflow (1064)

Patient Problem Emotional Changes (1831)

Event Date 11/27/2020

Event Type  No Answer Provided  

Event Description

Excessive blood backup in line despite flushing.Blood backup potentially from damaged bifuse or damaged filter.Pt had blood backing up the line (did not get to the filter) in evening, caught by rn when she came to assess pts dressing.She flushed the line to remove the blood back up and resolved issue.30 minutes later, blood backed up again, per parents pt was crying very hard after dressing had been reinforced.Attempted to use gravity to return blood, however was not returning.Flushed line again at main line and blood cleared.Blood had also backed up to the other side of the bifurcate up to where the medline was clamped, attempted to flush this side, but would not flush.Clamped it back off.And with the assistance of break nurse, changed out bifurcate and medline using sterile procedure.As the main ivf tubing was not compromised this was connected to the new bifurcate.When the main ivf tubing was disconnected from the old bifurcate air appeared in the lower portion of the line up to the level of the filter.All of this air was removed from the line by opening the clamp to free flow before reconnecting the line to the patient.Sterile procedure was observed throughout.This is all the information available.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11272138
• MDR Text Key: 230063481
• Report Number: 11272138
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FILTER: MC9079, BIFUSE: MC33129
• Device Lot Number: FILTER: 4961948
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 DA