MAUDE Adverse Event Report: ICU MEDICAL, INC.; CATHETER, OXIMETER, FIBEROPTIC

Model Number 50328-07

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2016

Event Type  malfunction  

Event Description

The pulmonary artery catheter "kinked" while inserting it.It could not be moved through the cordis.The device was left in place and at the end of the case it was removed by removing the cordis at the same time.

• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 5443615
• MDR Text Key: 38428574
• Report Number: 5443615
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 50328-07
• Other Device ID Number: THREE WAVELENGTH OXIMETRY
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 80