MAUDE Adverse Event Report: CARDIACASSIST INC PROTEKDUO CANNULA; VENO-VENOUS CANNULA

Model Number 5140-4629

Device Problem Break (1069)

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Testing performed subsequent to receipt of the cannula on (b)(6) 2015 revealed that the kinking had caused a crack to form through the cannula body.Pressure testing confirmed that there was a fluid communicating path between the interior lumen and exterior surface of the cannula at the site of the kink.

Event Description

A patient with acute respiratory failure was supported using a protek duo cannula, a tandem heart pump and a maquet quadrox oxygenator for approximately 72 hours.The cannula was removed following death of the patient from complications of acute respiratory failure.The cannula performed as expected/intended without any sign of either device or patient related problems.Upon removal damage was noted just distal to the transition region of the cannula.The cannula was returned to cardiac assist for evaluation.

• Brand Name: PROTEKDUO CANNULA
• Type of Device: VENO-VENOUS CANNULA
• Manufacturer (Section D): CARDIACASSIST INC; 240 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: greg johnson ; 240 alpha drive; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 4934617
• MDR Text Key: 22855540
• Report Number: 2531527-2015-00004
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K140999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 07/23/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: AM051677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1