MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC QUICKDRAW VENOUS CANNULA W /KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	QD22
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Pt requiring vasoactive support went from unit to cath lab for iabp placement and back to cath lab for ecmo, until nurse identified air in ecmo circuit.Fda safety report id# (b)(4).

• Brand Name: QUICKDRAW VENOUS CANNULA W /KIT
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC ; irvine CA 92614
• MDR Report Key: 9636575
• Report Number: MW5092539
• Device Sequence Number: 14174229
• Product Code: DWF
• UDI-Device Identifier: 00690103182699
• UDI-Public: (01)00690103182699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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: 06/12/2021
• Device Model Number: QD22
• Device Catalogue Number: QD22
• Device Lot Number: 62292277
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR