MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

The patient right heart failure and pulmonary clotting was reported under medwatch mfr report# 2916596-2017-xxxxx.The serial number was not provided.No additional information was provided.A supplemental report will be submitted when the device analysis is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.The patient struggled with oxygenation in the postoperative period.The patient was placed on extracorporeal membrane oxygenation (ecmo) with a centrimag pump and another manufacturer¿s oxygenator.The patient was eventually weaned from ecmo support, and supported on an rvad.Another manufacturer¿s percutaneous rvad was in place from the operative procedure, and was subsequently removed after ecmo support had been established.The patient was experiencing right heart failure as well as pulmonary clotting that resulted in oxygenation issues.Rvad speed was adjusted throughout the postoperative period due to low volume.It was reported that the patient experienced hemolysis that was possibly related to the rvad.

Manufacturer Narrative

The right sided mechanical circulatory support device used at the time of the reported event was not returned for analysis.As a result, the report of hemolysis could not be confirmed during the investigation and the root cause could not be correlated to a device related issue.Hemolysis is listed in the centrimag instructions for use as a possible side effect that may be associated with the use of the centrimag blood pump.A review of the centrimag device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7031317
• MDR Text Key: 92035493
• Report Number: 2916596-2017-02750
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 116