MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number L102956

Device Problem Pumping Stopped (1503)

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

Event Date 02/15/2015

Event Type  malfunction  

Event Description

The patient was being supported with a ventricular assist device for acute support.It was reported that the motor stopped working and a motor malfunction alarm occurred.The motor and primary console were exchanged.No adverse issues were reported.

Manufacturer Narrative

Information was requested but not provided.Approximate age of device - 6 years, 9 months.The device is expected to return but has not been received.The patient remains ongoing.No further information is available.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

The reported motor malfunction alarm could not be confirmed through this evaluation.The returned motor was operated with the involved primary console without issue.The motor was then run for 2 days on a test primary console without any issues.The motor passed the functional test procedure and was found to function as intended.A review of the device history record revealed that 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: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; ch-8005 zurich; SZ
• 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: 4625145
• MDR Text Key: 16631034
• Report Number: 2916596-2015-00561
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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 Catalogue Number: L102956
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1