MAUDE Adverse Event Report: ICU MEDICAL INC. TRIOX; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 7110-EP8-H

Device Problem Retraction Problem (1536)

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

Event Date 02/18/2019

Event Type  malfunction  

Event Description

Anesthesia provider was inserting a pulmonary artery catheter when it became difficult to retract.The catheter could be advanced, just not retracted.The inability to place the catheter in the desired anatomical position, resulted in the anesthesia provider attempting to withdraw the catheter.The catheter could not be discontinued and removed without removing the cordis as well.

• Brand Name: TRIOX
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8472766
• MDR Text Key: 140601499
• Report Number: 8472766
• Device Sequence Number: 1
• Product Code: DQE
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7110-EP8-H
• Device Catalogue Number: 50328-07
• Device Lot Number: 3914350
• 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: 02/19/2019
• Date Report to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA