MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS LIFESCIENCES TRUWAVE 3CC/VAMP 60IN(150CM); TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	TRUWAVE 3CC/VAMP 60IN(150CM)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Arterial line tubing broke at the connection.Fda safety report id# (b)(4).

• Brand Name: EDWARDS LIFESCIENCES TRUWAVE 3CC/VAMP 60IN(150CM)
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 13514369
• Report Number: MW5107392
• Device Sequence Number: 5299769
• Product Code: DXO
• UDI-Device Identifier: 07460691955080
• UDI-Public: (01)07460691955080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: TRUWAVE 3CC/VAMP 60IN(150CM)
• Device Catalogue Number: PXVMP160
• Device Lot Number: 63872072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 61 KG