MAUDE Adverse Event Report: CARDIACASSIST, INC. TANDEMHEART VENO-VENOUS CANNULA (PROTEKDUO)

Model Number 5410-4629

Device Problems Bent (1059); Kinked (1339); Material Deformation (2976)

Patient Problems Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

An adult male patient was hospitalized in respiratory distress that appeared to be a consequence of viral infecton.His condition deteriorated to the point that he was placed on cardiopulmonary support with a rotaflow pump, a quadrox oxygenator and a protek duo veno-venous cannula.After about 3 days on support, flow rates which had been stable at about 4 liters per minute (lpm) dropped to 2.5 lpm.An x-ray showed what appeared to be a kink in the cannula.Attempts to reposition the cannula did not improve the situation.Support continued at the lower flow rate until the next day, at which time the cannula was removed and mechanical support was discontinued.Visual examination of the cannula revealed a pinched, or kinked, area at the transition area between the thicker proximal section and the thinner distal section, as well as several other areas of deformation.The patient remained in critical, but stable, condition on ventilator support several days after explant.

• Brand Name: TANDEMHEART VENO-VENOUS CANNULA (PROTEKDUO)
• Type of Device: VENO-VENOUS CANNULA
• Manufacturer (Section D): CARDIACASSIST, INC.; pittsburgh PA
• Manufacturer Contact: greg johnson ; 240 alpha dr.; pittsburgh, PA 15238
• MDR Report Key: 4438495
• MDR Text Key: 5393741
• Report Number: 2531527-2014-00007
• 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: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2015

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: 08/31/2015
• Device Model Number: 5410-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: AM047238
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Treatment: MAQUET ROTAFLOW PUMP AND MAQUET QUADROX OXYGENATOR
• Patient Outcome(s): Required Intervention