MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER; CATHETER, INTRAVASCULAR, GENERAL-PURPOSE

Model Number 10031

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problem Death (1802)

Event Type  Death  

Event Description

It was reported that during a ecls procedure the venous line pressure moved from -70 to -10.The issue was supposed to be with the avalon catheter.The product was discarded by the user facility.Pt suffered of h1n1 and eventually did expire.(b)(4).Mfr ref #8010762-2014-00111.

• Brand Name: AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, GENERAL-PURPOSE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; restatt ; GM
• MDR Report Key: 3692477
• MDR Text Key: 18791132
• Report Number: 3008355164-2014-00046
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2014,02/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10031
• Device Catalogue Number: 70106-3538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 159