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

Model Number L102956

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: no patient was involved in this event.Approximate age of device: approximate age of device cannot be calculated at this time.Investigation results will be provided in a subsequent submission.

Event Description

It was reported that the centrimag motor has a small cut and kinking on the cable.No patient was involved with this event.

Manufacturer Narrative

Section h3, h4, h8: additional information.Manufacturers investigation conclusion: the report of a small kink and cut in the centrimag motor's cable was confirmed and reproduced during testing of the returned centrimag motor (serial number (b)(6)).The returned motor was evaluated and tested by the service depot.The rental motor was returned after the end of a rental period.Visual inspection of the returned motor confirmed a small tear and kink in the motor cable's outer jacket, adjacent to the motor body bend relief.Additionally, continuity testing of the motor's cable revealed an intermittent open connection in the bearing phase b2 (ib2+/ib2-) connection when then cable was manipulated in the area of the observed cut, consistent with conductor breakdown.Although the root cause of the observed damage could not be conclusively determined, it appeared to be a result of repetitive bending or twisting of the cable during use.As an added note, it was observed that the motor was manufactured in august of 2010, making the motor over 8 years old.The defective motor was scrapped.Corrective action has been initiated to investigate issues related to conductor breakdown in the motor cable and reports of similar damage will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• 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: 8546894
• MDR Text Key: 144446604
• Report Number: 2916596-2019-01985
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1