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

Model Number PX36N

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

Patient Problem Air Embolism (1697)

Event Description

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

• Brand Name: TRUWAVE (30 CC)/36 IN (90CM) PRE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.; irvine CA 92614
• MDR Report Key: 16337557
• MDR Text Key: 309307205
• Report Number: MW5114812
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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 Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic