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

Model Number 102956

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement in this event.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the motor cable is kinking.There was no alarms associated with the event and the motor will not be returned.No further information was provided.

Manufacturer Narrative

Correction - it was reported by the customer that no product would be returning.However the centrimag motor (serial number (b)(4)) was received on 31jul2019.Manufacturer's investigation conclusion: the reported event of the centrimag motor¿s cable kinking was confirmed.The returned centrimag motor (serial number (b)(4)) was inspected under a work order on 13aug2019.An image of the motor¿s cable was also provided.The motor¿s cable was observed to have a kink near its connection to the motor.It was determined that the motor would be scrapped due to the cable¿s kinking being unrepairable.As a result, the motor was not tested further.The root cause of the cable¿s kinking was unable to be determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3 & g2: corrected information.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8920945
• MDR Text Key: 155209908
• Report Number: 2916596-2019-03943
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1