MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Catalog Number L102956

Device Problem Pumping Stopped (1503)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device ¿ 10 years (calculated from the purchase date).The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was being supported with an extracorporeal circulatory support pump.It was reported that the centrimag motor periodically shut off when in use.Reportedly, the source of the issue was the centrimag motor cord.If the cord was wiggled the motor would return to operation.The motor was replaced, resulting in a temporary pump stoppage.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of the centrimag motor having cord issues was confirmed and reproduced during testing of the returned motor.The returned motor was evaluated and tested by tech service under work order #53216412.The reported complaint was confirmed during testing.While running the motor, it did not shut off when the motor cable was manipulated, but issues with pump rotation were observed.The pump would studder and speed would drop.The motor was forwarded to ppe for additional testing.The impedance values of the motor current barring phases were measured.The measurements revealed that the impedance of the bearing phase a2 connection would change from approximately 2 ohm to an open connection (infinite resistance), indicating conductor breakdown in the motor cable.All other lines measured within the normal ranges.Although the root cause of this damage could not be conclusively determined, it appeared to be a result of repetitive bending or twisting of the power cable.The defective motor was scrapped.Corrective action has been initiated to investigate similar issues and reports of similar events will continue to be tracked and monitored.The labeling has an emergency/troubleshooting section for the primary console.The recommended practice, whenever there is a console or motor malfunction, is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console to continue patient support.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Reports of damage to the cable that connects the motor to the console are being addressed through the manufacturer's corrective/preventative action system and a voluntary field action for the centrimag motor (z-0103-2019) dated (b)(6) 2018, was sent to customers.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7722486
• MDR Text Key: 115198505
• Report Number: 2916596-2018-02919
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1