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

Model Number MC9079

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

Air bubbles present between filter and patient.I was changing hal (hyperalimentation) and il (intravenous) lines infusing through a picc line.I had primed the tubing, checked for and dispelled air bubbles in the line.Once the line was attached to the patient, air bubbles developed between the filter and the patient.The infusion was immediately stopped, a new filter was primed and reattached to the patient.Again air bubbles appeared in the same area of the line.Another rn then primed a whole new line, no further air bubbles noted.The remaining stock of filters of that lot number were pulled for testing.

• 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: 10703948
• MDR Text Key: 212105864
• Report Number: 10703948
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC9079
• Device Lot Number: 4915987
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA