MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS

Model Number 201-10002

Device Problem Pumping Stopped (1503)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

The motor is not a single use device.Approximate age of the device is 6 months and 12 days (calculated from the manufacture date of the motor).During the investigation, no faulty behavior was determined with the returned primary console and flow probe (refer to medwatch mfr report # 2916596-2018-01274 for the report on the primary console).Therefore, a defect sensor inside the motor body was highly suspected to be the root cause of the complaint.Most probably, that is the reason for a temperature rise inside the motor body and the restart of the primary console.The returned motor was operated for an extended period of time and the reported alarm and primary console restart was reproduced during testing.This event was reproduced when the motor was tested with both the returned primary console and again with a test primary console, confirming a motor issue.The motor has a field time of circa 6 months.Since the motor is potted, the root cause of the issue could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was placed on biventricular extracorporeal circulatory support.It was reported that an m6 alarm appeared on the primary console screen.An interruption in support occurred.It was reported that the patient experienced unspecified symptoms and harm due to the event.After the primary console and motor were quickly exchanged, the patient continued with biventricular support.No additional information was provided.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7835535
• MDR Text Key: 118867984
• Report Number: 2916596-2018-03538
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140061
• UDI-Public: 7640135140061
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2017
• 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 Outcome(s): Hospitalization; Required Intervention