MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC TRUWAVE; PRESSURE TRANSDUCER

Catalog Number PX260

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 04/12/2015

Event Type  No Answer Provided  

Event Description

Nursing staff changes patients monitoring tubing sets twice a week per hospital protocol.Recently staff has had a difficult time disconnecting the edwards lifescience truwave monitoring tubing set at the junction that connects to the patient.This results in lines not being changed creating a potential infection risk for already vulnerable micu patients.The specific device was not retained by the hospital.However this has been a problem throughout this particular area of the hospital.There have been multiple occurrences of this issue with this device.

• Brand Name: TRUWAVE
• Type of Device: PRESSURE TRANSDUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; one edwards way; irvine CA 92614
• MDR Report Key: 4773804
• MDR Text Key: 5805032
• Report Number: 4773804
• Device Sequence Number: 2
• Product Code: DXO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 04/23/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: PX260
• Device Lot Number: 59968104
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IV DRIP AND A MONITORING MACHINE