MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE (30 CC) / 36 IN (90 CM) PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number "PX36N"

Device Problems Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2023

Event Type  Injury  

Event Description

Loose connector on transducer - while in operating room air was entrained into an ecmo circuit while in use on a pt though a loose connector.

• Brand Name: TRUWAVE (30 CC) / 36 IN (90 CM) PRESSURE MONITORING SET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 16304523
• MDR Text Key: 308928870
• Report Number: MW5114686
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: "PX36N"
• Device Lot Number: 64453340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 23 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic