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

Model Number PX284AN

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

Early 60¿s male with history of coronary artery disease and recent shortness of breath.7 days post op from coronary artery bypass graft x 1 and monitored in cvicu.A new package of truwave 3cc pressure tubing opened to change arterial line.When the tubing was primed, tubing was wet and there was a puddle on the floor.A crack was visualized in the tubing and the tubing was removed, without known harm to patient.Manufacturer response for transducer, pressure, catheter tip, truwave (per site reporter) will obtain.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16843322
• MDR Text Key: 314306193
• Report Number: 16843322
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07460691950245
• UDI-Public: (01)07460691950245(17)240908(11)220909(10)64603249
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2023

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
• Device Model Number: PX284AN
• Device Catalogue Number: PX284AN
• Device Lot Number: 64603249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Weight: 88 KG