MAUDE Adverse Event Report: ICU MEDICAL TD TORQUE; THERMODILUTION PA CATHETER

Model Number 41239-06

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2018

Event Type  malfunction  

Event Description

Pulmonary artery catheter was placed at bedside.Wedge waveform was visible.When fellow drew back air from syringe blood was returned.Pa catheter was immediately removed.No apparent harm to patient.

• Brand Name: TD TORQUE
• Type of Device: THERMODILUTION PA CATHETER
• Manufacturer (Section D): ICU MEDICAL; 457 w. virginia ave.; punta gorda FL 33950
• MDR Report Key: 7816670
• MDR Text Key: 118261805
• Report Number: 7816670
• Device Sequence Number: 1
• Product Code: DYG
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41239-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1