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

Model Number 102956

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of a motor fault failure was confirmed.The returned centrimag motor was tested.Per analysis, an open connection was found within the motor¿s cable when the cable was manipulated at the end of its bend relief during resistance testing.The open connection was found in the b2 line, which is responsible for the input and output current of bearing phase b2.An open connection in this line would cause motor disconnected: m2 alarms.An insulation test was also performed, and the motor passed insulation testing.The reported event was reproduced and confirmed.Upon connection to a test console and test flow probe, the console alarm with motor disconnected: m2.Due to the analysis deeming an open connection within the motor¿s cable, the motor was scrapped.The root cause of the motor fault appeared to be conductor breakdown within the motor¿s cable.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that a motor failure alarm was noticed during clinical simulations.The console alarmed motor fault failure and was switched to a second motor.The alarm resolved.When the original motor was placed back on the console the alarm reappeared.The motor in question was not used on a patient.Motor was sent back for evaluation.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG 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: 9038376
• MDR Text Key: 158677490
• Report Number: 2916596-2019-04342
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1