MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR; CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

Catalog Number 102956

Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)

Patient Problem Thrombus (2101)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: primary console: serial number (b)(4), manufacture date: july, 2013; ship date: 10/03/2013.The motor is not a single use device.Approximate age of the device is 8 years, 1 month calculated from the ship date of the motor (10/31/2008).The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was placed on extracorporeal membrane oxygenation (ecmo) on (b)(6) 2016.On (b)(6) 2016, it was reported that the patient developed a clot in the pump.This equipment had been placed on the patient on (b)(6) 2016.It was reported that the motor became hot to touch, and that no alarm was elicited from the console.The pump was exchanged; however, the motor would not operate the pump.After the console and motor were exchanged to the backup, the system functioned as expected.It was reported that on (b)(6) 2016, the patient expired, likely from a clotting disorder.It was reported that the patient's condition had started to deteriorate prior to the event.No additional information was provided.

Manufacturer Narrative

Device evaluation: the centrimag motor and primary console were returned for evaluation.The motor was allowed to run for an extended period of time without any issues being reproduced.The primary console was also tested for several days with the returned motor and no issues were identified.Both the motor and the console operated as intended with no issues found.A review of the device history records for both the centrimag primary console and the centrimag motor revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6237630
• MDR Text Key: 64367577
• Report Number: 2916596-2017-00045
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/18/2017

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 Catalogue Number: 102956
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: 06/26/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 60