MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE 3CC/84IN (210CM) TRANSDUCER KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Stopcock in transducer kit (edwards lifesciences truwave 3cc/84in (210 cm) cracked while infusing saline through cvp/rap line.

• Brand Name: TRUWAVE 3CC/84IN (210CM) TRANSDUCER KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10372397
• MDR Text Key: 201888745
• Report Number: 10372397
• Device Sequence Number: 1
• Product Code: DXO
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1