MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC CENTRIMAG MOTOR

Catalog Number 201-10002

Device Problem Pumping Stopped (1503)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

Gender and weight were not provided.The motor is not a single use device.Approximate age of the device is 8 years and 10 months; calculated from the manufacture date of the motor.The event occurred at (b)(6) hospital, (b)(6).Device analysis: the motor and primary console were returned for analysis.Analysis of the data retrieved from the returned primary console confirmed the reported motor fault alarm.The primary console was evaluated and passed all testing with no faults found.The returned motor was functionally tested using laboratory equipment and the reported ¿motor fault error¿ was able to be reproduced.When the motor cable was bent during the functional testing, the motor intermittently produced a short circuit from motor phase ¿a¿ to the chassis/ground outer shield of the cable.Visual inspection of the motor cable did not reveal any cuts or other damage.The device has been in use in the field for almost 9 (nine) years.The investigation could not determine a point in time when the intermittent short circuit on the motor cable occurred.A review of the device history record revealed no deviations from manufacturing or quality assurance specifications.No further information is available.The manufacturer is closing the file on this event.

Event Description

The patient was placed on an extracorporeal circulatory support device for extracorporeal membrane oxygenation on (b)(6) 2015.On the same day, during patient transport, it was reported that a motor fault error occurred.A review of the device log files found that pumping had stopped during the event.After switching to the backup centrimag motor, the system functioned properly.The patient experienced unspecified symptoms, but reportedly was not harmed during the event.As of (b)(6) 2015, the patient status had improved and the patient had been discharged back to the care of the referring hospital.No additional information was provided.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5426503
• MDR Text Key: 37844639
• Report Number: 2916596-2016-00258
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2016

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: 201-10002
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2007
• 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
• Treatment: CENTRIMAG PRIMARY CONSOLE, (B)(4)
• Patient Age: 1 DA