MAUDE Adverse Event Report: EDWARDS 8.5 FR PRESEP CATHETER

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Information (3190)

Event Date 07/30/2014

Event Type  malfunction  

Event Description

We had a presep catheter inserted for a pt for scvo2 monitoring.I did invitro calibration and it was ok until i hit start, after the catheter was inserted.Scvo2 didn't show any activity, so i did invivo calibration and it showed wall artifact or wedge detected, reposition catheter.I repositioned the pt, changed the optic module 3 times and ev1000 monitor as well.Still it didn't work.Recalibrated and continued as it shows in the message.When i hit continue, the monitor shows message fault oximetry: light range.Md requested to keep the line, since the line in situ with cvp monitoring even though no scvo2 monitoring can be obtained.Dates of use: (b)(6) 2014 diagnosis or reason for use: scvo2 monitoring and fluid infusion.Event abated after use stopped or dose reduced: no.Lot# unknown.

• Brand Name: 8.5 FR PRESEP CATHETER
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS
• MDR Report Key: 4025117
• MDR Text Key: 4883119
• Report Number: MW5037810
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/08/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR