MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CO-SET+ DELIVERY SYSTEM (CARDIAC OUTPUT TUBING AND SYRINGE); CARDIAC OUTPUT UNIT, TUBING AND SYRINGE

Catalog Number 93610

Device Problems Crack (1135); Defective Device (2588)

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

Event Date 05/08/2017

Event Type  malfunction  

Event Description

Patient had 5 french swan placed in catheter lab and patient was readmitted to pediatric intensive care unit.When attaching the cardiac output tubing, the tubing and syringe cracked twice and were defective.Had to get a 3rd set up for it to work.

• Brand Name: CO-SET+ DELIVERY SYSTEM (CARDIAC OUTPUT TUBING AND SYRINGE)
• Type of Device: CARDIAC OUTPUT UNIT, TUBING AND SYRINGE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 6590277
• MDR Text Key: 75941343
• Report Number: 6590277
• Device Sequence Number: 1
• Product Code: DPW
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 93610
• Device Lot Number: 59966174
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR