MAUDE Adverse Event Report: ICU MEDICAL TRIOX/CCO PA CATHETER

Model Number 8F, 110CM, J-TIP, LF

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Type  malfunction  

Event Description

Clot formation noted on the continuous cardiac output mixed venous pa catheter during open heart cardiac surgery.Upon opening the right atrium, surgeon noted fresh clot present around entire thermal heating filament on the pa catheter.This clot was immediately removed and no harm to the pt is evident.

• Brand Name: TRIOX/CCO PA CATHETER
• Type of Device: PA CATHETER
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 5380446
• MDR Text Key: 36493949
• Report Number: MW5059393
• Device Sequence Number: 1
• Product Code: DQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: 8F, 110CM, J-TIP, LF
• Device Catalogue Number: 52516-15
• Device Lot Number: 3129158
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1