MAUDE Adverse Event Report: TELEFLEX ARROW; TUNNELED DIALYSIS CATHETER

Device Problem Air Leak (1008)

Patient Problems Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 06/03/2015

Event Type  Injury  

Event Description

The clamp on the tunnelled dialysis catheter was closed, but did not fully engage the tubing.The pt was being removed from crrt at the time.The nurse head a rush of air and the pt desaturated and became unresponsive.Nurse aspirated the catheter with a syringe.Critical care doctors to bedside, pt placed in lateral decubitus position and trendelenburg catheter aspirated again and pt sent to (b)(4).

• Brand Name: ARROW
• Type of Device: TUNNELED DIALYSIS CATHETER
• Manufacturer (Section D): TELEFLEX; 3015 carrington mill blvd; NC 27560
• MDR Report Key: 4847339
• MDR Text Key: 5810987
• Report Number: MW5043063
• Device Sequence Number: 1
• Product Code: MSD
• 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: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR