MAUDE Adverse Event Report: EDWARD LIFESCIENCES LLC VAMP; CATHETER, CONTINUOUS FLUSH

Lot Number 60719466

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 04/19/2018

Event Type  malfunction  

Event Description

An adult arterial line sampling manifold connected to the ecmo circuit had a crack and was leaking.Rn noticed it and changed it out for a new one.

• Brand Name: VAMP
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARD LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7550565
• MDR Text Key: 109450944
• Report Number: 7550565
• Device Sequence Number: 0
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 60719466
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BABY HAD BEEN PLACED ON ECMO V-A IN (B)(6) 2018
• Patient Age: 1 YR
• Patient Weight: 8