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 06/25/2019

Event Type  Injury  

Manufacturer Narrative

No patient was involved.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported the centrimag motor cable had kinking issues.No additional information was provided.

Manufacturer Narrative

Additional information.Manufacturer's investigation conclusion: the reported event of a kink in the centrimag motor¿s cable was confirmed.The returned centrimag motor (serial number (b)(6) was tested under a work order on 25jun2019.A customer-owned motor was received without any information as to why it was shipped.A complimentary functional checkout could not be performed due to a kink in the motor¿s cable.The motor was stated to be returning to the customer as is, however it was also stated that the motor should no longer be used by the customer and should be scrapped.The work order was updated on 18sep2019 with new information regarding the motor¿s disposition.The delivery of the centrimag motor was canceled.Instead, the motor was scrapped for precautionary safety purposes.The root cause of the damage to the motor¿s cable was unable to be determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• 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: 8789353
• MDR Text Key: 150990582
• Report Number: 2916596-2019-03098
• 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
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 03/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1