MAUDE Adverse Event Report: ABBOTT VASCULAR INC. COPILOT; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 1003331

Device Problem Backflow (1064)

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

Event Date 07/29/2020

Event Type  malfunction  

Event Description

The copilot bleedback control valve had blood in the pressure line causing a back-up in the line.

• Brand Name: COPILOT
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 10413050
• MDR Text Key: 203121306
• Report Number: 10413050
• Device Sequence Number: 1
• Product Code: DTL
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1003331
• Device Catalogue Number: 1003331
• Device Lot Number: 60225167
• 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: 08/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 50