MAUDE Adverse Event Report: ICU MEDICAL INC SPINNING SPIROS CLOSED MALE LUER, RED CAP; STOPCOCK, I.V. SET

Model Number CH2000S-C

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 11/21/2020

Event Type  malfunction  

Event Description

Circle priming chemo and using spiros cap.As i was priming the tubing through the pump, pump started beeping partial occlusion and as i traced the tubing, noticed a small drip between the connection end of tubing and the spiros cap.Gauze applied to site and wet spot noted.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 10939886
• MDR Text Key: 219331767
• Report Number: 10939886
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CH2000S-C
• Device Lot Number: 4991021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA