MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Model Number 201-10002

Device Problems Break (1069); Device Stops Intermittently (1599); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

The patient's age, gender and weight were not provided.Unique identifier (udi) # (device identifier): device was manufactured prior to the udi labeling implementation.The motor is not a single use device.Approximate age of the device is 9 years, 6 months (calculated from the manufacture date of the motor).Device evaluation the reported event of a motor failure alarm was confirmed and reproduced during the evaluation of the returned centrimag motor.During visual inspection small scratches to the body of the motor were noted; however, this is considered cosmetic damage and doesn't affect the functionality of the motor.The motor was connected to the returned console.Slight movement of the motor cable triggered a motor disconnect and system fault alarm, reproducing the reported event.The issue was isolated to the returned motor and it was determined that there was breakdown in wires of the motor cable, causing the pump to stop and the console to alarm.The root cause of the conductor breakdown in the motor cable could not be conclusively determined during the investigation; however, a capa has been initiated to investigate the issue further.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.

Event Description

On (b)(6) 2018, it was reported that during the investigation of the returned device, wire damage was found, which caused pump stoppages.The event occurred during training while connected to a mock loop.No patient involvement.No further information was provided at the time of this report.

Manufacturer Narrative

Added conclusion codes.It was noted that the evaluation codes were inadvertently omitted from the initial medwatch report.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich CH-80 05; SZ CH-8005
• MDR Report Key: 7522637
• MDR Text Key: 108856350
• Report Number: 2916596-2018-01756
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1